MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,08 report with the FDA on 2014-07-17 for DORNHOFFER ALTO PARTIAL 695 manufactured by Grace Medical, Inc..
[21243424]
Patient received a partial ossicular prosthesis. Patient initially had perfect hearing results. Patient suddenly developed max conductive hearing loss. An exam had shown the prosthesis in position but too short and deep to malleus.
Patient Sequence No: 1, Text Type: D, B5
[21280727]
The patient is to be scheduled for a revision surgery at some point in the future. When additional information is received and/or the prosthesis is returned, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1057421-2014-00001 |
| MDR Report Key | 3964885 |
| Report Source | 05,06,08 |
| Date Received | 2014-07-17 |
| Date of Report | 2014-06-19 |
| Date Mfgr Received | 2014-06-19 |
| Device Manufacturer Date | 2010-10-01 |
| Date Added to Maude | 2014-07-30 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. BILL GRAHAM |
| Manufacturer Street | 8500 WOLF LAKE DR., STE. 110 |
| Manufacturer City | MEMPHIS TN 38133 |
| Manufacturer Country | US |
| Manufacturer Postal | 38133 |
| Manufacturer Phone | 9073860990 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DORNHOFFER ALTO PARTIAL |
| Generic Name | PARTIAL OSSICULAR REPLACEMENT PROSTH |
| Product Code | ETA |
| Date Received | 2014-07-17 |
| Catalog Number | 695 |
| Lot Number | 21829 |
| Device Expiration Date | 2015-10-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GRACE MEDICAL, INC. |
| Manufacturer Address | MEMPHIS TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-07-17 |