FemSoft® Insert Female Urethral Insert 72203Recalls & reported problems
Rochester Medical Corporation · Female Urethral Insert · Class 3
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741011115), received between Apr 9, 2018 and Apr 9, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Device Dislodged or Dislocated1
- Difficult to Remove1
- Migration or Expulsion of Device1
Patient problems
- Discomfort1
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 9, 2018Migration or Expulsion of Device; Device Dislodged or Dislocated; Migration or Expulsion of Device; Difficult to Remove; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE FEMSOFT DEVICE COULD NOT BE LOCATED FOR REMOVAL. THE COMPLAINANT STATED THAT SHE INSERTED THE DEVICE ON (B)(6) 2018, BUT NOTICED THAT IT FELT UNCOMFORTABLE SHORTLY AFTER PLACEMENT. TWO HOURS LATER, SHE DECIDED TO REMOVE THE DEVICE BUT COULD NOT GRASP IT FOR REMOVAL. SHE ALSO REPORTED THAT SHE IS AN EXPERIENCED USER WITH THIS DEVICE AND HAS BEEN USING IT FOR SEVERAL YEARS WITHOUT ANY PREVIOUS ISSUES. ON THE FOLLOWING DAY, (B)(6) 2018, SHE VISITED HER DOCTOR¿S OFFICE WHO RECOMMENDED THAT SHE GO TO THE EMERGENCY ROOM AS A CONCERN THAT THE DEVICE MAY STILL BE INSIDE OF HER. UPON ARRIVAL, THE HOSPITAL DECIDED TO ADMIT HER SO THAT THEY COULD RUN FURTHER TESTS TO LOCATE THE DEVICE. A PELVIC X-RAY WAS PERFORMED WHICH REVEALED NEGATIVE RESULTS. HOWEVER; A CT SCAN OF HER ABDOMEN/PELVIS WAS PERFORMED ON (B)(6) 2018 WHICH DID REVEAL A FOREIGN OBJECT. THE UROLOGIST THEN PERFORMED A PROCEDURE THROUGH HER URETHRA TO REMOVE THE DEVICE AND SHE WAS LATER DISCHARGED FROM THE HOSPITAL. RECORDS INDICATE THAT THIS PRODUCT WAS LAST SOLD TO THE COMPLAINANT ON (B)(6) 2014. BASED ON DOCUMENT # (B)(4), THE PRODUCT HAS BEEN DISCONTINUED AND HAS NOT BEEN MANUFACTURED SINCE THE ACQUISIT
Patient problems: Discomfort; Foreign Body In Patient
MAUDE report 7410045 ↗
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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