FDA Adverse Event
Injury
Summary report: N
SURGICAL GUT SUTURE -PLAIN
MDR report key: 4193620
·
Received October 22, 2014
Report
- Report Number
- 2210968-2014-14855
- Event Type
- Injury
- Date Received
- October 22, 2014
- Report Date
- October 4, 2014
- Manufacturer
- ETHICON INC.
- Product Code
- GAL
- PMA / PMN Number
- K946173
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PROCEDURE PERFORMED WAS A BLEPHAROPLASTY.
Additional Manufacturer Narrative · 1
(B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.
Additional Manufacturer Narrative · 1
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 AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST OPERATIVELY, THE PATIENT DEVELOPED A GRANULOMA. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 672017 | SURGICAL GUT SUTURE -PLAIN | SUTURE, ABSORBABLE, NATURAL | GAL | ETHICON INC. | UNK | HEZ048 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |