FDA Adverse Event
Injury
Summary report: N
BIOSYN UD 4/0 18 P-13
MDR report key: 4243892
·
Received November 11, 2014
Report
- Report Number
- 1219930-2014-01046
- Event Type
- Injury
- Date Received
- November 11, 2014
- Report Date
- November 4, 2014
- Manufacturer
- COVIDIEN, FORMERLY US SURGICAL A DIVISON
- Product Code
- GAM
- PMA / PMN Number
- K000037
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
ACCORDING TO THE REPORTER: THE PATIENT CAME BACK AFTER REVERSE OF VASECTOMY BECAUSE THE WOUND OPENED UP. PATIENT ALREADY BEEN DISCHARGED? YES.HOW WAS THE WOUND CLOSED AFTER THE DEHISCENCE? (RE-OPERATION IN THE OR, OUTPATIENT, IN THE OFFICE) TWO WERE REAPPROXIMATED IN CLINICAL OFFICE USING A CHROMIC SUTURE; OTHERS WERE TOLD TO APPLY STERI-STRIPS TO AID WITH APPROXIMATION;SOME WERE SIMPLY TOLD APPLY POLYSPORIN AND ALLOW THE WOUND TO HEAL BY SECONDARY INTENTION.WHAT WAS USED TO CLOSE THE WOUND AFTER THE DEHISCENCE? SEE #5.HOW IS THE PATIENT DOING NOW? OK.PATIENT COMORBIDITIES NO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 726003 | BIOSYN UD 4/0 18 P-13 | SUTURE | GAM | COVIDIEN, FORMERLY US SURGICAL A DIVISON | SM5690 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |