MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2010-12-06 for PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT 70142144 manufactured by Gyrus Ent L.l.c..
[18961223]
The device has not been returned for evaluation. No medical expert has made a claim that the implant is the cause. No medical expert has made a claim of malfunction. No other complaints on file for this item.
Patient Sequence No: 1, Text Type: N, H10
[18986502]
Reportedly a patient has experienced multiple adverse side effects since surgery. The side effects are unusual and constant.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1037007-2010-00008 |
| MDR Report Key | 1917920 |
| Report Source | 00 |
| Date Received | 2010-12-06 |
| Date of Report | 2010-12-06 |
| Date of Event | 2010-03-01 |
| Date Mfgr Received | 2010-11-17 |
| Device Manufacturer Date | 2004-10-01 |
| Date Added to Maude | 2010-12-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR DOLAN MILLS |
| Manufacturer Street | 2925 APPLING RD. |
| Manufacturer City | BARTLETT TN 38133 |
| Manufacturer Country | US |
| Manufacturer Postal | 38133 |
| Manufacturer Phone | 9013730200 |
| Manufacturer G1 | GYRUS ENT L.L.C. |
| Manufacturer Street | 2925 APPLING RD. |
| Manufacturer City | BARTLETT TN 38133 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38133 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT |
| Product Code | ETB |
| Date Received | 2010-12-06 |
| Catalog Number | 70142144 |
| Lot Number | 0441166183 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS ENT L.L.C. |
| Manufacturer Address | BARTLETT TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-12-06 |