FDA Adverse Event
Injury
Summary report: N
SUPRIS RETROPUBIC KIT
MDR report key: 6883805
·
Received September 21, 2017
Report
- Report Number
- 2125050-2017-00455
- Event Type
- Injury
- Date Received
- September 21, 2017
- Report Date
- September 20, 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, MEDWATCH 5071730 - PATIENT EXPERIENCED URGE INCONTINENCE, SEXUAL PAIN AND RIGHT LEG PAIN, BAD LOW DETRUSOR CAPACITY, CONSTIPATION, IRRITABLE BOWEL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 663430 | SUPRIS RETROPUBIC KIT | SURGICAL MESH | OTN | COLOPLAST A/S | 5195622400 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |