FDA Adverse Event
Injury
Summary report: N
UHR BIPOLAR 26X47MM
MDR report key: 2032666
·
Received March 17, 2011
Report
- Report Number
- 2249697-2011-00326
- Event Type
- Injury
- Date Received
- March 17, 2011
- Date of Event
- February 24, 2011
- Report Date
- February 24, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- KWL
- PMA / PMN Number
- K800207
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
IF ADD'L INFO BECOMES AVAILABLE THEN IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT. CAT # 6260-9-126, LOT# UNK, DESCRIPTION: 26MM STD LFIT V40 HEAD. CAT # 1059-4512, LOT# UNK, DESCRIPTION: ACCOLADE DISTAL SPACER MEDIUM-STANDARD. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S PAIN.
Description of Event or Problem · 1
IT WAS REPORTED THAT,"PT IS HAVING A LOT OF PAIN AND SHE IS ITCHING A LOT IN HER SACRUM AREA AND IT MAKES HER URINATE WHEN SHE SCRATCHES THAT AREA."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UHR BIPOLAR 26X47MM | IMPLANT | KWL | STRYKER ORTHOPAEDICS MAHWAH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Other| R |