FDA Adverse Event
Injury
Summary report: N
UNKNOWN PURSTRING DEVICE
MDR report key: 4301411
·
Received December 5, 2014
Report
- Report Number
- 2647580-2014-01029
- Event Type
- Injury
- Date Received
- December 5, 2014
- Date of Event
- January 19, 2012
- Report Date
- November 11, 2014
- Manufacturer
- COVIDIEN, FORMERLY USSC PUERTO RICO INC
- Product Code
- GDJ
- PMA / PMN Number
- K901107
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4). INITIAL REPORT SENT TO FDA ON 12/05/2014.
Description of Event or Problem · 1
PROCEDURE TYPE: HEMORRHOID. ACCORDING TO THE REPORTER: THERE WAS EXTENSIVE BLEEDING FOLLOWING THE PROCEDURE AND REQUIRED REOPERATION. THE PATIENT HAD DEVELOPED A VERY LARGE HEMATOMA AND A LOOP COLOSTOMY WAS PERFORMED AS A RESULT. IT WAS REVEALED THAT THE STAPLES WERE PLACED TOO DEEP. THE PATIENT WAS DISCHARGED BUT CONTINUED TO HAVE BOWEL AND BLADDER PROBLEMS SECONDARY TO THE INJURY FROM THE SUTURES PLACED. A FISTULA FORMED DURING THIS PROCESS. THE PATIENT REQUIRED PLACEMENT OF A FOLEY CATHETER AND MULTIPLE COURSES OF ANTIBIOTICS. THERE WAS UNANTICIPATED TISSUE DAMAGE.
Description of Event or Problem · 1
THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2012. TRANSVERSE LOOP COLOSTOMY REVERSED (B)(6) 2012.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 786253 | UNKNOWN PURSTRING DEVICE | DISPOSABLE SURGICAL STAPLING DEVICE | GDJ | COVIDIEN, FORMERLY USSC PUERTO RICO INC | UNKNOWN PURSTRING | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Other |