FDA Adverse Event
Injury
Summary report: N
PROXIMATE PPH PROCEDURE SET
MDR report key: 1021958
·
Received March 6, 2008
Report
- Report Number
- 1527736-2008-01336
- Event Type
- Injury
- Date Received
- March 6, 2008
- Report Date
- February 12, 2008
- Manufacturer
- ETHICON ENDO-SURGERY, INC. (CINCINNATI)
- Product Code
- GDW
- PMA / PMN Number
- K051301
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
INFORMATION NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.
Description of Event or Problem · 1
IT WAS REPORTED POST OF FROM A PPH PROCEDURE, THE PT WAS READMITTED MULTIPLE TIMES FOR DRAINAGE OF ABSCESS, POSSIBLE FISSURE, EUA AND LATERAL SPHINCTEROTOMY. PT HAS NORMAL ANO-RECTUM; THE FISSURE IS HEALING FISSURE AND A NORMAL INTACT STAPLE LINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROXIMATE PPH PROCEDURE SET | GDW | ETHICON ENDO-SURGERY, INC. (CINCINNATI) | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |