FDA Adverse Event
Malfunction
Summary report: N
ETHILON BLU 100CM 1 KP-3 CONV
MDR report key: 3876527
·
Received June 17, 2014
Report
- Report Number
- 2210968-2014-04168
- Event Type
- Malfunction
- Date Received
- June 17, 2014
- Date of Event
- March 13, 2014
- Manufacturer
- ETHICON INC.
- Product Code
- GAR
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 356684 | ETHILON BLU 100CM 1 KP-3 CONV | SUTURE, NONABSORBABLE, SYNTHETIC | GAR | ETHICON INC. | GL5BWPE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |