FDA Adverse Event
Injury
Summary report: N
SUPRIS RETROPUBIC KIT
MDR report key: 6760992
·
Received August 2, 2017
Report
- Report Number
- 2125050-2017-00332
- Event Type
- Injury
- Date Received
- August 2, 2017
- Report Date
- August 2, 2017
- Manufacturer
- COLOPLAST A/S
- Product Code
- OTN
- PMA / PMN Number
- K111233
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE. SHOULD ADDITIONAL FACTS PROMPT US TO ALTER OR SUPPLEMENT ANY INFORMATION OF CONCLUSIONS CONTAINED IN THE ORIGINAL MDR OR IN ANY PRIOR SUPPLEMENTAL REPORTS, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
ACCORDING TO THE AVAILABLE INFORMATION ON MEDWATCH # 5071042- SLING WAS INSERTED, SINCE THEN MORE INCONTINENCE, BLOATING, CONSTIPATION, LOW DESTRUCTOR CAPACITY WENT FOR TESTS ENDED UP THAT THERE IS BLADDER DIVERTICULUM, VESICOURETERAL REFLUX, ENDED UP WITH SELF CAUTERIZATION. FURTHER DR.'S APPOINTMENTS TO COME TO SEE WHAT TO DO NEXT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 540964 | SUPRIS RETROPUBIC KIT | SURGICAL MESH | OTN | COLOPLAST A/S | 5195622400 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |