FDA Adverse Event
Malfunction
Summary report: N
AIGIS-R LARGE
MDR report key: 4319125
·
Received December 10, 2014
Report
- Report Number
- 3005619263-2014-00014
- Event Type
- Malfunction
- Date Received
- December 10, 2014
- Date of Event
- September 3, 2014
- Report Date
- September 3, 2014
- Manufacturer
- TYRX, INC.
- Product Code
- FTL
- PMA / PMN Number
- K130943
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCT: 2 - 1888TC ST. JUDE LEADS, IMPLANTED: (B)(6) 2008. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE ENVELOPE WAS IMPLANTED THREE DAYS AFTER THE EXPIRATION DATE. 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 |
|---|---|---|---|---|---|---|---|
| 799179 | AIGIS-R LARGE | MESH, SURGICAL, POLYMERIC | FTL | TYRX, INC. | CMRM6133 | 14F25473 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00085 YR | C4TR01, IPG, 6725, ADAPTOR |