FDA Adverse Event
Death
Summary report: N
RENASYS AB DRSG KIT W SOFTPORT
MDR report key: 5010700
·
Received August 18, 2015
Report
- Report Number
- 3006760724-2015-00077
- Event Type
- Death
- Date Received
- August 18, 2015
- Date of Event
- July 15, 2015
- Report Date
- December 17, 2015
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- OMP
- PMA / PMN Number
- K083375
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING EXPLORATORY LAPAROTOMY THE PATIENT WAS TREATED WITH A RENASYS OPEN ABDOMINAL KIT APPLIED. UPON A SUBSEQUENT DRESSING CHANGE (DURING THEATRE REVIEW) IT WAS OBSERVED THAT THE BOWEL HAD ADHERED TO THE MESH BEING USED TO APPLY TENSION TO FASCIA. (B)(6) HAD OCCURRED AND THE PATIENT SUBSEQUENTLY DIED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING EXPLORATORY LAPAROTOMY THE PATIENT WAS TREATED WITH A RENASYS OPEN ABDOMINAL KIT APPLIED. UPON A SUBSEQUENT DRESSING CHANGE (DURING THEATRE REVIEW) IT WAS OBSERVED THAT THE BOWEL HAD ADHERED TO THE MESH BEING USED TO APPLY TENSION TO FASCIA. FISTULAE AND BOWEL NECROSIS HAD OCCURRED AND THE PATIENT SUBSEQUENTLY DIED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 545218 | RENASYS AB DRSG KIT W SOFTPORT | NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP | OMP | SMITH & NEPHEW, INC. | 66800980 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 94 YR | Death |