FDA Adverse Event
Injury
Summary report: N
TYRX ABSORBABLE ANTIBACTERIAL ENVELOPE
MDR report key: 9150925
·
Received October 3, 2019
Report
- Report Number
- 3005619263-2019-00032
- Event Type
- Injury
- Date Received
- October 3, 2019
- Date of Event
- September 4, 2019
- Report Date
- October 3, 2019
- Manufacturer
- TYRX, INC.
- Product Code
- FTL
- PMA / PMN Number
- K130943
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- 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 PATIENT EXPERIENCED A POSSIBLE INFECTION AT THE IMPLANT SITE. THE PATIENT WAS GIVEN ANTIBIOTICS AND THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND ANTIBACTERIAL ABSORBABLE ENVELOPE REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 943918 | TYRX ABSORBABLE ANTIBACTERIAL ENVELOPE | MESH, SURGICAL, POLYMERIC | FTL | TYRX, INC. | TYRX-AAE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | DTMB2D1 CRT-D |