FDA Adverse Event
Malfunction
Summary report: N
DISPOSABLE EXTENSION CABLE
MDR report key: 3516501
·
Received December 6, 2013
Report
- Report Number
- 3516501
- Event Type
- Malfunction
- Date Received
- December 6, 2013
- Date of Event
- August 21, 2013
- Report Date
- November 7, 2013
- Manufacturer
- REMINGTON MEDICAL, INC.
- Product Code
- DSA
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MI, US
Narratives
Description of Event or Problem · 1
PACING CABLES DID NOT OPEN COMPLETELY, SEVERAL CABLES/LOT NUMBERS TRIED. UNABLE TO INSERT POST OF PACING WIRE INTO THE CABLE. AFTER MANIPULATION, SURGEON FORCED IT IN. NO UNAFFECTED LOT NUMBERS AVAILABLE IN OR, CSS, WAREHOUSE, OR SUPPLIER. CABLES ABLE TO BE SAVED; GIVEN TO VALUE ANALYSIS DEPARTMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 633572 | DISPOSABLE EXTENSION CABLE | CABLE, TRANSDUCER AND ELECTRODE, PATIENT | DSA | REMINGTON MEDICAL, INC. | FL-601-97 | 131262 | |
| 633573 | DISPOSABLE EXTENSION CABLE | CABLE, TRANSDUCER AND ELECTRODE, PATIENT | DSA | REMINGTON MEDICAL, INC. | FL-601-97 | 130941 | |
| 633648 | DISPOSABLE EXTENSION CABLE | CABLE, TRANSDUCER AND ELECTRODE, PATIENT | DSA | REMINGTON MEDICAL, INC. | FL-601-97 | 131092 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 14 YR | NOT APPLICABLE. |