FDA Adverse Event
Malfunction
Summary report: N
MONOMEND MT 3/0 36" (90CM) DS24 (M) VPL
MDR report key: 3938882
·
Received June 13, 2014
Report
- Report Number
- 2916714-2014-00424
- Event Type
- Malfunction
- Date Received
- June 13, 2014
- Report Date
- June 9, 2014
- Manufacturer
- B. BRAUN SURGICAL SA
- Product Code
- GAM
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
US REPORTING AGENT NOTIFIED ON: (B)(4) 2014. REPORTED DEVICE IS FOR VET USE ONLY; HOWEVER SIMILAR PRODUCTS THAT ARE FOR HUMAN USE HAVE SIMILAR PRODUCTION CIRCUMSTANCES. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.
Description of Event or Problem · 1
VET STAFF REPORTED THERE WAS A CLUSTER OF SUTURES THAT HAVE CAUSED SUTURE REACTIONS THEY STATED THAT OUT OF LOT #113203; THERE WERE 6 PACKS USED AND OUT OF THOSE 6 PACKS, 4 CAUSED THE REACTIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 351250 | MONOMEND MT 3/0 36" (90CM) DS24 (M) VPL | SYNTHETIC ABSORBABLE SUTURE | GAM | B. BRAUN SURGICAL SA | 40065 | 113203 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |