FDA Adverse Event
Malfunction
Summary report: N
AIGIS-R LARGE
MDR report key: 8271445
·
Received January 23, 2019
Report
- Report Number
- 3005619263-2019-00011
- Event Type
- Malfunction
- Date Received
- January 23, 2019
- Date of Event
- December 28, 2018
- Report Date
- January 23, 2019
- Manufacturer
- TYRX, INC.
- Product Code
- FTL
- UDI-DI
- 00763000101619
- PMA / PMN Number
- K130943
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE ANTIBACTERIAL ABSORBABLE ENVELOPE THAT WAS IMPLANTED WAS PAST IT¿S EXPIRATION DATE BY ONE MONTH. THE ANTIBACTERIAL ABSORBABLE ENVELOPE REMAINS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 63484 | AIGIS-R LARGE | MESH, SURGICAL, POLYMERIC | FTL | TYRX, INC. | CMRM6133 | R104672R27 | 00763000101619 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR |