FDA Adverse Event
Other
Summary report: N
SURGIMEND
MDR report key: 3935911
·
Received June 26, 2014
Report
- Report Number
- 3004170064-2014-00140
- Event Type
- Other
- Date Received
- June 26, 2014
- Date of Event
- February 25, 2014
- Report Date
- June 26, 2014
- Manufacturer
- TEI BIOSCIENCES INC.
- Product Code
- FTM
- PMA / PMN Number
- 060984
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HISTORY RECORD FOR THIS LOT WAS REVIEWED AND EVERYTHING WAS IN ORDER.
Description of Event or Problem · 1
ONE DEVICE WAS IMPLANTED ON (B)(6) 2014 FOR PENILE AUGMENTATION. SUBSEQUENTLY THE PT DEVELOPED AN EXUDATE AND DISCHARGE ON (B)(6) 2014. THE DEVICE WAS EXPLANTED ON (B)(6) 2014. NO ADDITIONAL INFO WAS PROVIDED. THIS TYPE OF OUTCOME IS TYPICALLY ASSOCIATED WITH A SURGICAL SITE INFECTION ALTHOUGH THIS HAS NOT BEEN CONFIRMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 374403 | SURGIMEND | SURGICAL MESH | FTM | TEI BIOSCIENCES INC. | 606-400-002 | 1303039 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Required Intervention |