FDA Adverse Event
Injury
Summary report: N
UNK WOMEN'S HEALTH MEHS PRODUCT
MDR report key: 3486583
·
Received November 20, 2013
Report
- Report Number
- 1018233-2013-08300
- Event Type
- Injury
- Date Received
- November 20, 2013
- Report Date
- October 10, 2013
- Manufacturer
- C.R. BARD, INC. (COVINGTON)
- Product Code
- OTP
- PMA / PMN Number
- UNK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT FAMILY FOR THIS WOMEN'S HEALTHCARE PRODUCT IS UNK; THEREFORE, BARD IS UNABLE TO DETERMINE THE ASSOCIATED LABELING AND DFMEA TO REVIEW. IF ADD'L INFO IS RECEIVED, A F/U REPORT WILL BE SUBMITTED. (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 SERIOUS AND PERMANENT INJURIES, PAIN, DISFIGUREMENT, PHYSICAL IMPAIRMENT, PROGRESSION OF EXISTING CONDITIONS AND HAD REQUIRED AND WILL REQUIRE CONTINUED MEDICAL TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 601497 | UNK WOMEN'S HEALTH MEHS PRODUCT | OTP, PAG | OTP | C.R. BARD, INC. (COVINGTON) | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention| S |