FDA Adverse Event
Malfunction
Summary report: N
AIGIS-R LARGE
MDR report key: 4319136
·
Received December 10, 2014
Report
- Report Number
- 3005619263-2014-00015
- Event Type
- Malfunction
- Date Received
- December 10, 2014
- Date of Event
- October 7, 2014
- Report Date
- October 7, 2014
- Manufacturer
- TYRX, INC.
- Product Code
- FTL
- PMA / PMN Number
- K130943
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
.
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PHYSICIAN INSISTED ON USING THE ENVELOPE DURING THE IMPLANT PROCEDURE EVEN THOUGH IT EXPIRED FIVE DAYS PREVIOUSLY. THE ENVELOPE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 802995 | AIGIS-R LARGE | MESH, SURGICAL, POLYMERIC | FTL | TYRX, INC. | CMRM6133 | 14G22483 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |