FDA Adverse Event
Injury
Summary report: N
POLYSORB 7-0 18 VL SE-140-8 D/A
MDR report key: 4241499
·
Received November 10, 2014
Report
- Report Number
- 1219930-2014-01031
- Event Type
- Injury
- Date Received
- November 10, 2014
- Date of Event
- October 9, 2014
- Report Date
- October 27, 2014
- Manufacturer
- COVIDIEN, FORMERLY US SURGICAL A DIVISON
- Product Code
- GAM
- PMA / PMN Number
- K963253
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
PROCEDURE: EYE SURGERY.ACCORDING TO THE REPORTER: INITIALLY, THE PROCEDURE WAS COMPLETED WIHTOUT PROBLEMS. HOWEVER, POST-OPERATIVELY, IT WAS FOUND THAT THE SUTURE HAD COMPLETELY DISSOLVED BEFORE 30-35 DAYS. TO CORRECT THE PROBLEM, THE PATIENT WAS RE-OPERATED ON AND RE-SUTURED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 722859 | POLYSORB 7-0 18 VL SE-140-8 D/A | POLYSORB | GAM | COVIDIEN, FORMERLY US SURGICAL A DIVISON | L1897K | B4D1079X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |