FDA Adverse Event
Malfunction
Summary report: N
MONOCRYL PLUS SUTURE
MDR report key: 4173933
·
Received October 15, 2014
Report
- Report Number
- 2210968-2014-14599
- Event Type
- Malfunction
- Date Received
- October 15, 2014
- Date of Event
- September 22, 2014
- Report Date
- September 26, 2014
- Manufacturer
- ETHICON INC.
- Product Code
- GAM
- PMA / PMN Number
- K050845
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
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. 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 AN ANIMAL UNDERWENT AN OVARIOHYSTERECTOMY ON (B)(6) 2014 AND SUTURE WAS USED. POSTOPERATIVELY ON (B)(6) 2014, IT WAS NOTED THAT THE SUTURE BROKE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 654108 | MONOCRYL PLUS SUTURE | SUTURE, ABSORBABLE, SYNTHETIC | GAM | ETHICON INC. | UNK | GM6409 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |