FDA Adverse Event
Injury
Summary report: N
AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM - ANTERIOR
MDR report key: 3321284
·
Received August 16, 2013
Report
- Report Number
- 1018233-2013-06379
- Event Type
- Injury
- Date Received
- August 16, 2013
- Report Date
- January 12, 2016
- Manufacturer
- C.R. BARD, INC. (COVINGTON)
- Product Code
- FTL
- PMA / PMN Number
- K082571
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
THE SAMPLE WAS NOT RETURNED. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE (IFU) WHICH ACCOMPANIES ALL DEVICES CURRENTLY ADDRESSES POTENTIAL RISKS ASSOCIATED WITH SURGICALLY IMPLANTED MATERIALS. (B)(4). LAWYER-FILED REPORT - (B)(6).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
. IT WAS REPORTED BY THE PT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PT HAS EXPERIENCED PAIN, DISABILITY AND IMPAIRMENT.
Description of Event or Problem · 1
PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED BLOOD LOSS/OOZING, EXTRUSION, DEFECT, ELEVATED WHITE BLOOD CELL LEVEL, NON-SURGICAL AND ADDITIONAL SURGICAL INTERVENTIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 395675 | AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM - ANTERIOR | FTL | C.R. BARD, INC. (COVINGTON) | NA | CVSH0014 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Required Intervention | AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM-POSTERIOR| LOT # UNK, REF # (B)(4)| LOT # UNK, REF # (B)(4) |