FDA Adverse Event
Injury
Summary report: N
VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910)
MDR report key: 1516235
·
Received October 22, 2009
Report
- Report Number
- 2210968-2009-01208
- Event Type
- Injury
- Date Received
- October 22, 2009
- Date of Event
- January 1, 2008
- Report Date
- September 21, 2009
- Manufacturer
- ETHICON, INC.
- Product Code
- GAM
- PMA / PMN Number
- K022715
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DATE SENT TO THE FDA: 10/21/2009. CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.
Description of Event or Problem · 1
CUSTOMER REPORTED THAT HE OBSERVED REDNESS AND IRRITATION ALONG THE SUTURE LINE AT AN UNSPECIFIED TIME FOLLOWING A BREAST REDUCTION PROCEDURE. THE SURGICAL PROCEDURE AND EVENT REPORTEDLY OCCURRED IN 2008. THE PT WAS TREATED WITH ORAL STEROIDS AND THE REACTION RESOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) | SUTURE, ABSORBABLE | GAM | ETHICON, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention | LOCALLY INSTILLED ANTIBIOTICS - NOT SPECIFIED |