FDA Adverse Event
Injury
Summary report: N
UNKNOWN WOMEN'S HEALTH PRODUCT
MDR report key: 2881158
·
Received December 14, 2012
Report
- Report Number
- 1018233-2012-02121
- Event Type
- Injury
- Date Received
- December 14, 2012
- Report Date
- June 8, 2018
- Manufacturer
- C.R. BARD, INC. (COVINGTON)
- Product Code
- UNK
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- UNKNOWN
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT FAMILY FOR THIS WOMEN'S HEALTHCARE PRODUCT IS UNKNOWN. THEREFORE WE ARE UNABLE TO DETERMINE THE ASSOCIATED LABELING AND DFMEA TO REVIEW.
Description of Event or Problem · 1
IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED INJURIES, INFECTIONS, PAIN, DISCHARGE AND MULTIPLE CORRECTIVE SURGERIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN WOMEN'S HEALTH PRODUCT | UNK | UNK | C.R. BARD, INC. (COVINGTON) | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Female | Required Intervention | BARD AVAULTA PLUS.| SURGICAL ABSORBABLE HEMOSTAT.| SURGIFOAM. |