FDA Adverse Event
Malfunction
Summary report: N
SURGIWRAP
MDR report key: 9671796
·
Received February 5, 2020
Report
- Report Number
- 3004661493-2018-00002
- Event Type
- Malfunction
- Date Received
- February 5, 2020
- Date of Event
- December 9, 2015
- Report Date
- February 5, 2020
- Manufacturer
- MAST BIOSURGERY USA INC
- Product Code
- FTL
- PMA / PMN Number
- K050332
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 501
Narratives
Additional Manufacturer Narrative · 1
NOT ENOUGH INFORMATION HAS BEEN PROVIDED TO MAKE A DETERMINATION OF WHETHER THE SURGIWRAP IS THE CAUSE OF THE INCREASED UPTAKE ON THE PET SCAN.
Description of Event or Problem · 1
PET SCAN SHOWED HYPERMETABOLIC LESION (UPTAKE IN PET). FALSE POSITIVE PET CAN RESULT DUE TO THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 136392 | SURGIWRAP | MESH, SURGICAL, POLYMERIC | FTL | MAST BIOSURGERY USA INC | SURGIWRAP | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Other |