FDA Adverse Event
Injury
Summary report: N
PROXIMATE PPH PROCEDURE SET
MDR report key: 1035401
·
Received April 25, 2008
Report
- Report Number
- 1527736-2008-02462
- Event Type
- Injury
- Date Received
- April 25, 2008
- Date of Event
- March 22, 2008
- Report Date
- April 1, 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
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS USED DURING A HEMORRHOIDECTOMY. THE PATIENT WAS RETURNED TO THE OR TWO DAYS POSTOP (03/24/2008). UNKNOWN AT THIS TIME WHAT EXACTLY HAS OCCURRED.
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 |