FDA Adverse Event
Malfunction
Summary report: N
3.5MM INSERTER
MDR report key: 1021604
·
Received March 25, 2008
Report
- Report Number
- 2242816-2008-00037
- Event Type
- Malfunction
- Date Received
- March 25, 2008
- Date of Event
- March 2, 2008
- Report Date
- March 12, 2008
- Manufacturer
- EBI
- Product Code
- LXH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ADD'L LOT # 14-441044.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE TIP OF THE 3.5MM INSERTER (LONG) BROKE OFF AND THAT THE TIP OF THE 3.5MM INSERTER (SHORT) STRIPPED DURING USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 3.5MM INSERTER | LXH | EBI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |