FDA Adverse Event
Injury
Summary report: N
CONSTAVAC DRAIN CBC II
MDR report key: 29748
·
Received February 6, 1996
Report
- Report Number
- MW1008263
- Event Type
- Injury
- Date Received
- February 6, 1996
- Date of Event
- January 31, 1996
- Report Date
- February 2, 1996
- Manufacturer
- STRYKER CORP.
- Product Code
- CAC
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- IN, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
PHYSICIAN REMOVED DRAIN AND RIGHT DRAIN BROKE OFF IN PT. REMOVAL OF DRAIN WAS UNWITNESSED BY PERSONNEL. PT REQUIRED ARTHROTOMY ON 1/31/96 TO REMOVE RETAINED FOREIGN BODY. 6" OF PLASTIC DRAIN WAS REMOVED. PT BILATERAL TOTAL KNEE REPLACEMENT 1/30/96.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONSTAVAC DRAIN CBC II | AUTOTRANSFUSION APPARATUS | CAC | STRYKER CORP. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Required Intervention |