FDA Adverse Event
Other
Summary report: N
RSP SHOULDER
MDR report key: 1912764
·
Received November 2, 2010
Report
- Report Number
- 1644408-2010-00593
- Event Type
- Other
- Date Received
- November 2, 2010
- Date of Event
- October 27, 2010
- Report Date
- October 27, 2010
- Manufacturer
- ENCORE MEDICAL, L.P.
- Product Code
- KWS
- PMA / PMN Number
- K051075
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
REVISION SURGERY - THE PT HAD A BAD FALL AND DISLOCATED HIS SHOULDER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RSP SHOULDER | HUMERAL SOCKET | KWS | ENCORE MEDICAL, L.P. | 53810992 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Required Intervention | 508-32-104, LOT 53813198 |