FDA Adverse Event
Injury
Summary report: N
PROXIMATE PPH PROCEDURE SET
MDR report key: 1111064
·
Received August 13, 2008
Report
- Report Number
- 3005075853-2008-01140
- Event Type
- Injury
- Date Received
- August 13, 2008
- Date of Event
- July 24, 2008
- Report Date
- July 29, 2008
- Manufacturer
- ETHICON ENDO-SURGERY, LLC
- Product Code
- GDW
- PMA / PMN Number
- K051301
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DATE SENT: 8/12/2008. INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A STAPLED ANOPEXY PROCEDURE; THE KNIFE CUT, BUT THE STAPLES DID NOT FORM INTO THE B SHAPE AND STAYED IN A C SHAPE. THE PT BLED HEAVILY IN RECOVERY, POST SURGERY AND WAS READMITTED TO THEATRES FOR CORRECTION AND SURGEON HAD TO HAND SUTURE. THE PT WAS DISCHARGED HOME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROXIMATE PPH PROCEDURE SET | GDW | ETHICON ENDO-SURGERY, LLC | NA | E4LD45 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |