FDA Adverse Event
Malfunction
Summary report: N
THREADED END (UTS) ADAPTER
MDR report key: 3146928
·
Received May 31, 2013
Report
- Report Number
- 1213649-2013-00021
- Event Type
- Malfunction
- Date Received
- May 31, 2013
- Date of Event
- April 23, 2013
- Report Date
- May 28, 2013
- Manufacturer
- CADENCE INC
- Product Code
- DTL
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
ON (B)(6) 2013, IT WAS REPORTED THE ADAPTER DID NOT HAVE A THROUGH-HOLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 241194 | THREADED END (UTS) ADAPTER | ADAPTER | DTL | CADENCE INC | 6529 | W005287/1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |