UNKNOWN PUREWICK HOME CARE DISPOSABLE
Report
- Report Number
- 1018233-2025-10673
- Event Type
- Injury
- Date Received
- December 2, 2025
- Date of Event
- November 20, 2025
- Report Date
- December 4, 2025
- Manufacturer
- C.R. BARD INC. (COVINGTON) -1018233
- Product Code
- NZU
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE REPORTED PRODUCT NUMBER IS UNKNOWN. THE UDI NUMBER FOR THIS PRODUCT IS NOT AVAILABLE. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.
THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE THIS INVESTIGATION DID NOT RESULT IN ANY ADDITIONAL FINDINGS AND NO SAMPLE WAS AVAILABLE FOR EVALUATION. A LABELING REVIEW COULD NOT BE PERFORMED SINCE NO MATERIAL NUMBER WAS PROVIDED. THE DHR REVIEW COULD NOT BE PERFORMED WITHOUT A LOT NUMBER. NO ADDITIONAL ACTIONS CAN BE TAKEN AT THIS TIME. THE REPORTED PRODUCT NUMBER IS UNKNOWN. THE UDI NUMBER FOR THIS PRODUCT IS NOT AVAILABLE. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.
IT WAS REPORTED THAT THE CRITICAL CARE NURSE STATED THAT WHEN FILLING OUT AN ONLINE SURVEY, A PATIENT¿S CAREGIVER INDICATED THEY STRONGLY DISAGREED WITH THE FOLLOWING STATEMENTS: ¿WHEN THINKING OF THE THREE MONTHS PRIOR, THE PERSON YOU CARE FOR FEELS DRY WHEN USING THE PUREWICK SYSTEM FOR WOMEN IN A SEATED POSITION¿ AND ¿WHEN THINKING OF THE THREE MONTHS PRIOR, THE PUREWICK SYSTEM FOR WOMEN ADEQUATELY CAPTURED THE URINE OF THE PERSON I CARE FOR WHEN THEY USED IT IN A SEATED POSITION¿ BECAUSE THE CATHETER DID NO REMAIN IN PLACE AND LEAKED. THE PATIENT¿S CAREGIVER INDICATED THE PERSON THEY CARE FOR EXPERIENCED SKIN IRRITATION/INFLAMMATION (NO BROKEN SKIN) AND A URINARY TRACT INFECTION (UTI) AFTER USING THE PUREWICK SYSTEM FOR WOMEN IN THE PAST 3 MONTHS. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR THE URINARY TRACT INFECTION.
IT WAS REPORTED THAT THE CRITICAL CARE NURSE STATED THAT WHEN FILLING OUT AN ONLINE SURVEY, A PATIENT¿S CAREGIVER INDICATED THEY STRONGLY DISAGREED WITH THE FOLLOWING STATEMENTS: ¿WHEN THINKING OF THE THREE MONTHS PRIOR, THE PERSON YOU CARE FOR FEELS DRY WHEN USING THE PUREWICK SYSTEM FOR WOMEN IN A SEATED POSITION¿ AND ¿WHEN THINKING OF THE THREE MONTHS PRIOR, THE PUREWICK SYSTEM FOR WOMEN ADEQUATELY CAPTURED THE URINE OF THE PERSON I CARE FOR WHEN THEY USED IT IN A SEATED POSITION¿ BECAUSE THE CATHETER DID NO REMAIN IN PLACE AND LEAKED. THE PATIENT¿S CAREGIVER INDICATED THE PERSON THEY CARE FOR EXPERIENCED SKIN IRRITATION/INFLAMMATION (NO BROKEN SKIN) AND A URINARY TRACT INFECTION (UTI) AFTER USING THE PUREWICK SYSTEM FOR WOMEN IN THE PAST 3 MONTHS. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR THE URINARY TRACT INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2753933 | UNKNOWN PUREWICK HOME CARE DISPOSABLE | PUREWICK HOME CARE DISPOSABLE | NZU | C.R. BARD INC. (COVINGTON) -1018233 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Other |