FDA Adverse Event
Injury
Summary report: N
TRELEX MESH
MDR report key: 4927714
·
Received July 17, 2015
Report
- Report Number
- 2242352-2015-00616
- Event Type
- Injury
- Date Received
- July 17, 2015
- Date of Event
- January 7, 2003
- Report Date
- June 22, 2015
- Manufacturer
- MAQUET CARDIOVASCULAR LLC
- Product Code
- FTL
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVALUATION. WE ARE FOLLOWING UP WITH THE CUSTOMER FOR THE RETURN OF THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED. INTERNAL COMPLAINT NUMBER TRACKWISE # (B)(4).
Description of Event or Problem · 1
PATIENT STATE AS A RESULT OF THE IMPLANT SHE SUFFERED PAIN AND DISABILITY. PATIENT ALSO IMPLANTED WITH ETHICON TVT. TWO IMPLANT DATES PROVIDED ON THE COMPLAINT BUT DOES NOT SPECIFY WHICH GOES TO WHICH PRODUCT - (B)(6) 2003 AND (B)(6) 2010.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 464945 | TRELEX MESH | VASCULAR GRAFT | FTL | MAQUET CARDIOVASCULAR LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Disability |