Reported Reactions

Devices › Pump, breast, powered

Device brand name · Hgx

Pump In Style Advanced Breast Pump Metro Bag: medical device reports filed with FDA

165 reports name it, 2012–2015. Manufacturer given most often on reports: Medela. Product code HGX.

165
device reports naming the brand
0% of all MAUDE reports · about 12 a year
0
reports, 12 months to August 2026
0 in the 12 months before
88.5%
classified as malfunction
55.2% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

165 medical device reports received by FDA name the brand "Pump In Style Advanced Breast Pump Metro Bag" (hgx); the manufacturer given most often on reports is Medela; received from August 2012 to December 2015. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

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 malfunction (88.5%) and injury (9.7%); across all pump, breast, powered reports (product code HGX) death is recorded in 0% and malfunction in 55.2%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are break (33.9%), crack (17%) and detachment of device component (12.7%). The patient problems coded most often are inflammation, fungal infection 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

No report naming Pump In Style Advanced Breast Pump Metro Bag was received in the five years to August 2026; the latest was received in December 2015.

By year received

036722012: 1920122013: 7220132014: 5420142015: 202015

Event type and report source

Event type, as classified on the report

Death0%0
Injury9.7%16
Malfunction88.5%146
Other0%0
Not given1.8%3

Who filed the report

Manufacturer report100%165
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

Grey bar: all 5,563 reports carrying product code HGX. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)ReportsShareShare across product code
Breakthe device broke5633.9%18%
Crackthe device cracked2817%10.5%
Detachment of device component2112.7%5%
Scratched material148.5%2.8%
Material separation137.9%4.4%
Sparking137.9%5.8%
Component falling116.7%3.1%
Device operates differently than expectedthe device behaved unexpectedly84.8%3.9%
Failure to power up84.8%3.6%
Decrease in suction53%13.8%
Device slipped42.4%1.3%
Insufficient device problem information31.8%3.3%
Noise, audible31.8%2.4%
Protective measures problem31.8%2.1%
Material integrity problema problem with the device material21.2%1.5%
Overheating of device21.2%2%
Suction problem21.2%8.4%
Defective component10.6%0.3%
Detachment of device or device componentpart of the device came off10.6%0.2%
Device displays incorrect message10.6%0.1%

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
Inflammationinflammation74.2%
Fungal infectiona fungal infection31.8%
Painpain, site not specified31.8%
Rashskin rash21.2%
Burn(s)a burn10.6%
Itching sensation10.6%

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

In context

MeasurePump In Style Advanced Breast Pump Metro BagProduct code HGXAll MAUDE reports
Reports1655,56326,136,888
Share of that pool—3%0%
Classified as death, per 1,000 reports009
Classified as injury9.7%42.7%36.2%
Classified as malfunction88.5%55.2%62.3%
Filed by the manufacturer100%96.5%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 HGX

BrandReportsLatest 12 monthsClassified as death
Pump In Style Advanced Breast Pump Go Tote1,05200%
Pump In Style Breast Pump42100%
Breastpump Pnsa Starter34500%
Pump In Style Advanced Breast Pump Backpack32000%
Purely Yours25100%
Elvie25000%
Pump In Style Advanced - On-The-Go Tote20700%
Pump In Style Item Unk20200%
Symphony1,1631331.6%
Freestyle9,490260.1%

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 Pump In Style Advanced Breast Pump Metro Bag reports

How many FDA reports name Pump In Style Advanced Breast Pump Metro Bag?

165 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?

malfunction (88.5%) and injury (9.7%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

break (33.9%), crack (17%), detachment of device component (12.7%), scratched material (8.5%) and material separation (7.9%). 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 Pump In Style Advanced Breast Pump Metro Bag 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.