FDA Adverse Event
Injury
Summary report: N
VICRYL PLUS ANTIBACTERIAL SUTURE
MDR report key: 1025107
·
Received April 3, 2008
Report
- Report Number
- 2210968-2008-00235
- Event Type
- Injury
- Date Received
- April 3, 2008
- Report Date
- March 7, 2008
- Manufacturer
- ETHICON, INC.
- Product Code
- GAM
- PMA / PMN Number
- K022715
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DATE SENT TO THE FDA: 04/03/2008. CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.
Description of Event or Problem · 1
INTERNATIONAL CUSTOMER REPORTED THAT A PT PRESENTED WITH SWELLING AND SUTURE SPITTING BETWEEN SIX AND TWELVE WEEKS FOLLOWING AN ORTHOPEDIC PROCEDURE. SURGEON OPINES AN ALLERGIC REACTION. NO FURTHER INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VICRYL PLUS ANTIBACTERIAL SUTURE | SUTURE, ABSORBABLE | GAM | ETHICON, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |