Reported Reactions

Devices › Device, impotence, mechanical/hydraulic

Device brand name · Inflatable penile prosthesis

Titan Touch: medical device reports filed with FDA

2,066 reports name it, 2019–2023. Manufacturer given most often on reports: Coloplast A/S. Product code FHW.

2,066
device reports naming the brand
0% of all MAUDE reports · about 295 a year
0
reports, 12 months to August 2026
0 in the 12 months before
18.4%
classified as malfunction
8.8% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

FDA's MAUDE database holds 2,066 reports that name the brand "Titan Touch" (inflatable penile prosthesis), received between July 2019 and June 2023; the manufacturer given most often on reports is Coloplast A/S. Spellings of one product vary from report to report.

0 reports arrived in the 12 months to August 2026, and none 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 injury (81.6%) and malfunction (18.4%); across all device, impotence, mechanical/hydraulic reports (product code FHW) death is recorded in 0% and malfunction in 8.8%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are fluid/blood leak (21.9%), fracture (17.5%) and inflation problem (9.6%). The patient problems coded most often are bacterial infection, failure of implant and erosion. 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

05099Sep 2021: 62Oct 2021: 38Nov 2021: 21Dec 2021: 752022Jan 2022: 41Feb 2022: 45Mar 2022: 63Apr 2022: 52May 2022: 54Jun 2022: 59Jul 2022: 32Aug 2022: 54Sep 2022: 76Oct 2022: 81Nov 2022: 69Dec 2022: 722023Jan 2023: 66Feb 2023: 62Mar 2023: 67Apr 2023: 67May 2023: 99Jun 2023: 47Jul 2023: 0Aug 2023: 0Sep 2023: 0Oct 2023: 0Nov 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: 0Feb 2025: 0Mar 2025: 0Apr 2025: 0May 2025: 0Jun 2025: 0Jul 2025: 0Aug 2025: 0Sep 2025: 0Oct 2025: 0Nov 2025: 0Dec 2025: 02026Jan 2026: 0Feb 2026: 0Mar 2026: 0Apr 2026: 0May 2026: 0Jun 2026: 0Jul 2026: 0Aug 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

03496982019: 820192020: 36020202021: 59220212022: 69820222023: 4082023

Event type and report source

Event type, as classified on the report

Death0%0
Injury81.6%1,686
Malfunction18.4%380
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%2,065
Voluntary report0%1
User facility report0%0
Distributor report0%0
Not given0%0

Grey bar: all 38,562 reports carrying product code FHW. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)ReportsShareShare across product code
Fluid/blood leak45221.9%16.1%
Fracturea broken bone36117.5%5.4%
Inflation problem1999.6%13.8%
Pumping problem1979.5%1.6%
Breakthe device broke1065.1%2.6%
Inadequacy of device shape and/or size924.5%3.5%
Insufficient device problem information803.9%8.1%
Migrationthe device moved from where it was placed683.3%4.1%
Leak/splashthe device leaked623%2.2%
Material puncture/hole472.3%8.8%
Positioning problem321.5%0.3%
Physical resistance/sticking261.3%0.4%
Mechanical problema mechanical problem241.2%14.1%
Material twisted/bent231.1%0.1%
Deflation problem211%2.5%
Missing information190.9%0.1%
Material erosion180.9%0.6%
Failure to pump140.7%0.5%
Malposition of device140.7%2%
Material protrusion/extrusion140.7%0.2%

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
Bacterial infectiona bacterial infection894.3%
Failure of implant773.7%
Erosion572.8%
Painpain, site not specified482.3%
Skin erosion291.4%
Perforation120.6%
Wound dehiscencea wound reopened100.5%
Hernia80.4%
Deformity/ disfigurement70.3%
Discomfortdiscomfort70.3%
Hematomaa collection of blood under the skin or in tissue70.3%
Inflammationinflammation60.3%
Purulent discharge60.3%
Swelling/ edema60.3%
Appropriate clinical signs, symptoms and conditions term/code not available50.2%

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

In context

MeasureTitan TouchProduct code FHWAll MAUDE reports
Reports2,06638,56226,136,888
Share of that pool—5.4%0%
Classified as death, per 1,000 reports009
Classified as injury81.6%90.8%36.2%
Classified as malfunction18.4%8.8%62.3%
Filed by the manufacturer100%97.7%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 FHW

BrandReportsLatest 12 monthsClassified as death
AMS Inflatable Penile Prosthesis9,1196870%
AMS Inflatable Penile Prosthesis with Inhibizone6,66550%
Titan inflatable penile prosthesis family5,3261,7730%
Inflatable Penile Prosthesis3,49180%
Titan2,07800%
Alpha I1,28500%
AMS Ambicor Penile Prosthesis906280%
Dynaflex Penile Prosthesis80500%
Aphi71700%
Titan Otr38600%
Alpha I Inflatable Penile Prosthesis34900%
Hydroflex Penile Prosthesis31800%
Ambicor Penile Prosthesis31400%
Titan Touch Scro Zero Ang 18cm18400%
Surgitek Gel Mammary Implant36900.5%

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 Titan Touch reports

How many FDA reports name Titan Touch?

2,066 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.

What kinds of events are reported?

injury (81.6%) and malfunction (18.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

fluid/blood leak (21.9%), fracture (17.5%), inflation problem (9.6%), pumping problem (9.5%) and break (5.1%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (100%) and voluntary reports (0%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Titan Touch 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.