FDA Adverse Event
Malfunction
Summary report: N
COATED VICRYL (POLYGLACTIN 910) SUTURE
MDR report key: 1861272
·
Received October 1, 2010
Report
- Report Number
- 2210968-2010-01248
- Event Type
- Malfunction
- Date Received
- October 1, 2010
- Report Date
- September 3, 2010
- Manufacturer
- ETHICON, INC.
- Product Code
- GAM
- PMA / PMN Number
- K022269
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFO DERIVED FROM THE EVAL WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. 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 PT UNDERWENT AN EPISIOTOMY REPAIR PROCEDURE ON AN UNK DATE. DURING THE PROCEDURE, THE TIP OF THE NEEDLE BROKE. THE PT WAS X-RAYED AND THERE WAS NO NEEDLE FRAGMENT FOUND IN THE PT. THERE WERE NO ADVERSE PT CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COATED VICRYL (POLYGLACTIN 910) SUTURE | SUTURE, ABSORBABLE | GAM | ETHICON, INC. | NA | CE2038 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |