MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-08 for GOLDENBERG MALLEABLE PORP PROSTHESIS 140964 manufactured by Gyrus Acmi, Inc..
[27844495]
Patient Sequence No: 1, Text Type: N, H10
[27844496]
Before the implant was used, it was realized that the implant was broken in the package.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5136654 |
| MDR Report Key | 5136654 |
| Date Received | 2015-10-08 |
| Date of Report | 2015-09-29 |
| Date of Event | 2015-09-29 |
| Report Date | 2015-09-29 |
| Date Reported to FDA | 2015-09-29 |
| Date Reported to Mfgr | 2015-09-29 |
| Date Added to Maude | 2015-10-08 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GOLDENBERG MALLEABLE PORP PROSTHESIS |
| Generic Name | PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT |
| Product Code | ETB |
| Date Received | 2015-10-08 |
| Catalog Number | 140964 |
| Lot Number | 0631043033 |
| Device Expiration Date | 2016-08-31 |
| Device Availability | Y |
| Device Age | 10 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS ACMI, INC. |
| Manufacturer Address | 2925 APPLING ROAD BARTLETT TN 38133 US 38133 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-10-08 |