Reported Reactions

Devices › Catheter, straight

Device brand name · Intermittent catheter

Magic3 Go Male Catheter with SureGrip: medical device reports filed with FDA

470 reports name it, 2020–2026. Manufacturer given most often on reports: C R Bard Covington -1018233. Product code EZD.

470
device reports naming the brand
0% of all MAUDE reports · about 74 a year
12
reports, 12 months to August 2026
33 in the 12 months before
69.6%
classified as malfunction
71.6% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

470 medical device reports received by FDA name the brand "Magic3 Go Male Catheter with SureGrip" (intermittent catheter); the manufacturer given most often on reports is C R Bard Covington -1018233; received from March 2020 to July 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

12 reports arrived in the 12 months to August 2026, down 64% from 33 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (69.6%) and injury (30.4%); across all catheter, straight reports (product code EZD) death is recorded in 0.1% and malfunction in 71.6%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are improper chemical reaction (29.1%), component misassembled (11.7%) and biocompatibility (9.6%). The patient problems coded most often are urinary tract infection, appropriate clinical signs, symptoms and conditions term/code not available and pain. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Reports by month, five years

01427Sep 2021: 10Oct 2021: 8Nov 2021: 5Dec 2021: 142022Jan 2022: 8Feb 2022: 6Mar 2022: 10Apr 2022: 3May 2022: 11Jun 2022: 5Jul 2022: 14Aug 2022: 15Sep 2022: 13Oct 2022: 13Nov 2022: 10Dec 2022: 172023Jan 2023: 10Feb 2023: 5Mar 2023: 4Apr 2023: 5May 2023: 27Jun 2023: 27Jul 2023: 2Aug 2023: 1Sep 2023: 0Oct 2023: 1Nov 2023: 0Dec 2023: 02024Jan 2024: 0Feb 2024: 0Mar 2024: 0Apr 2024: 0May 2024: 0Jun 2024: 0Jul 2024: 0Aug 2024: 0Sep 2024: 0Oct 2024: 0Nov 2024: 0Dec 2024: 02025Jan 2025: 2Feb 2025: 4Mar 2025: 12Apr 2025: 1May 2025: 2Jun 2025: 6Jul 2025: 4Aug 2025: 2Sep 2025: 2Oct 2025: 0Nov 2025: 0Dec 2025: 22026Jan 2026: 1Feb 2026: 0Mar 2026: 0Apr 2026: 1May 2026: 3Jun 2026: 1Jul 2026: 2Aug 2026: 0

Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

By year received

0631252020: 11520202021: 10320212022: 12520222023: 8220232025: 3720252026: 82026

Event type and report source

Event type, as classified on the report

Death0%0
Injury30.4%143
Malfunction69.6%327
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%470
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

Grey bar: all 4,236 reports carrying product code EZD. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)ReportsShareShare across product code
Improper chemical reaction13729.1%9.2%
Component misassembled5511.7%2.9%
Biocompatibility459.6%3.6%
Incorrect measurementthe device measured wrongly398.3%3.7%
Difficult to insertthe device was hard to insert337%6.9%
Sharp edges245.1%5.8%
Component missing122.6%2.1%
Inadequacy of device shape and/or size81.7%1.6%
Nonstandard device81.7%1.3%
Patient device interaction problem81.7%0.8%
Inaccurate flow rate71.5%1.6%
Material deformation51.1%0.8%
Material twisted/bent51.1%3%
Defective devicethe device was defective40.9%13.7%
Device handling problem40.9%1%
Difficult to removethe device was hard to remove40.9%4.2%
Manufacturing, packaging or shipping problem40.9%0.8%
Material integrity problema problem with the device material40.9%3.5%
Material split, cut or torn40.9%0.1%
Scratched material40.9%0.7%

FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.

Patient problems coded

Patient problem (FDA code)ReportsShare
Urinary tract infectionbladder or urinary infection11223.8%
Appropriate clinical signs, symptoms and conditions term/code not available398.3%
Painpain, site not specified286%
Discomfortdiscomfort102.1%
Abrasion91.9%
Hemorrhage/blood loss/bleeding91.9%
No patient involvement91.9%
Sepsisa severe body-wide response to infection40.9%
Burning sensationa burning feeling30.6%
Skin inflammation/ irritation30.6%
Blood loss20.4%
Irritabilityirritability20.4%
Irritationirritation20.4%
Anemialow red blood cells10.2%
Cramp(s) /muscle spasm(s)10.2%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

MeasureMagic3 Go Male Catheter with SureGripProduct code EZDAll MAUDE reports
Reports4704,23626,136,888
Share of that pool—11.1%0%
Classified as death, per 1,000 reports019
Classified as injury30.4%28.1%36.2%
Classified as malfunction69.6%71.6%62.3%
Filed by the manufacturer100%99.3%94.9%

Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Other brands with product code EZD

BrandReportsLatest 12 monthsClassified as death
Magic3 Go Intermittent Urinary Catheter83090%
L3c0600 - Cure Products88100%
Cure Products64410%
Magic3 Go Male Coude Catheter with SureGrip439360.2%
Cure Catheter2161070%
Intermittent Rochester Catheters15900%
Magic3 Coude Intermittent Catheter with Sure-Grip Sleeve1,505710.1%
Gentlecath4023990%
Magic3 Intermittent Catheter530110%
Magic3 Intermittent Catheter with Sure-Grip Sleeve1,400220%
Bardex I.C. Foley Catheter4,0105620%
Bardex Lubricath Foley Catheter4,9236530%
Catheter24493.7%
Gentlecath Air1711360%
Gentlecath Other30700%

Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."

Questions about Magic3 Go Male Catheter with SureGrip reports

How many FDA reports name Magic3 Go Male Catheter with SureGrip?

470 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 12 in the latest 12 months.

What kinds of events are reported?

malfunction (69.6%) and injury (30.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

improper chemical reaction (29.1%), component misassembled (11.7%), biocompatibility (9.6%), incorrect measurement (8.3%) and difficult to insert (7%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Magic3 Go Male Catheter with SureGrip was at fault?

No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."

How do I report a problem with a medical device?

Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.

Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.