FDA Adverse Event
Injury
Summary report: N
VICRYL (POLYGLACTIN 910) SUTURE
MDR report key: 3202535
·
Received July 2, 2013
Report
- Report Number
- 2210968-2013-11918
- Event Type
- Injury
- Date Received
- July 2, 2013
- Date of Event
- May 8, 2013
- Report Date
- June 13, 2013
- Manufacturer
- ETHICON INC.
- Product Code
- GAM
- PMA / PMN Number
- K022269
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. THIS MEDWATCH REPORT IS IN RESPONSE TO RECEIPT OF (B)(4).
Additional Manufacturer Narrative · 1
(B)(4). IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT L5-S1 HEMI-LAMINOTOMY / DISKECTOMY (MINOR) AND RIGHT L5/S1 HEMI-LAMINOTOMY / DISKECTOMY (MAJOR). DURING THE PROCEDURE A PIECE OF THE NEEDLE BROKE OFF AND WAS MISSING. ADDITIONAL INFORMATION WAS REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 302333 | VICRYL (POLYGLACTIN 910) SUTURE | SUTURES - ABSORBABLE | GAM | ETHICON INC. | UNK | EK2557 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Other |