FDA Adverse Event
Injury
Summary report: N
DEXON II 6/0
MDR report key: 1233970
·
Received November 14, 2008
Report
- Report Number
- 9681850-2008-00021
- Event Type
- Injury
- Date Received
- November 14, 2008
- Date of Event
- October 17, 2008
- Report Date
- October 21, 2008
- Manufacturer
- GOSPORT - USS
- Product Code
- GAN
- PMA / PMN Number
- K951352
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INITIAL REPORT SENT: 11/14/08.
Description of Event or Problem · 1
PROCEDURE TYPE: STRABISMUS PROCEDURE. ACCORDING TO THE REPORTER: INITIAL PROCEDURE WAS ON THE EVENT DATE, AND THE PT WAS RE-OPERATED THE NEXT DAY, BECAUSE THE SUTURE BECAME LOOSE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DEXON II 6/0 | SYNTHETIC ABSORBABLE SUTURE | GAN | GOSPORT - USS | E8E0107C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 3 YR | Required Intervention |