MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2007-10-12 for manufactured by .
[22049518]
Hosp contact stated, that this unit had been out of service for some time, before it was used in this procedure. Dr used it in a procedure after this incident and there were no problems reported. It was tested after the procedure by a biotech, and again was found to be functioning well. Contact stated they needed more training on the unit; an in-service was scheduled and carried out.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610617-2007-00027 |
| MDR Report Key | 933373 |
| Report Source | 05,06 |
| Date Received | 2007-10-12 |
| Device Manufacturer Date | 2003-05-01 |
| Date Added to Maude | 2007-10-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | MITTLESTRASSE 8 POSTFACH 230 |
| Manufacturer City | TUTTLINGEN 78503 |
| Manufacturer Country | GM |
| Manufacturer Postal | 78503 |
| Manufacturer Phone | ** |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Product Code | LQS |
| Date Received | 2007-10-12 |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Device Sequence No | 1 |
| Device Event Key | 905386 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-10-12 |