FDA Adverse Event
Summary report: N
SURGIMEND 2.0
MDR report key: 1834090
·
Received September 8, 2010
Report
- Report Number
- 3004170064-2010-00011
- Date Received
- September 8, 2010
- Date of Event
- July 28, 2010
- Report Date
- September 8, 2010
- Manufacturer
- TEI BIOSCIENCES INC.
- Product Code
- FTM
- PMA / PMN Number
- 083898
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
ON (B)(6)2010, A (B)(6) MALE PATIENT, (B)(6), HEIGHT UNKNOWN, WAS OPERATED ON FOR AN ABDOMINAL HERNIA REPAIR. SURGIMEND, LOT NUMBER UNKNOWN, WAS USED TO REPAIR THE DEFECT. ON (B)(6)2010, THE PATIENT REQUIRED ADDITIONAL SURGERY FOLLOWING WOUND DEHISCENCE. THE PRODUCT WAS EXPLANTED AND WAS REPLACED WITH ANOTHER PIECE OF SURGIMEND. AT THE TIME OF THE SECOND SURGERY, THE SURGEON DID NOT BELIEVE THE WOUND DEHISCENCE OCCURRED BECAUSE OF FAILURE OF THE INITIAL IMPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SURGIMEND 2.0 | SURGICAL MESH | FTM | TEI BIOSCIENCES INC. | 606-200-016 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Required Intervention |