MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2005-05-02 for RICHARDS HAPEX OFFSET MALLCABLE PORP 70145892 manufactured by Gyrus Ent.
[380428]
Approximately 2 1/2 months post-op a partial ossicular replacement procedure the patient failed hearing test. During the ensuing exploratory surgery the surgeon discovered that the device had broken. He removed the device without incident, replaced it with a new one and the patient is now doing fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1037007-2005-00003 |
| MDR Report Key | 597868 |
| Report Source | 07 |
| Date Received | 2005-05-02 |
| Date of Report | 2005-05-02 |
| Date of Event | 2005-01-06 |
| Date Mfgr Received | 2005-04-14 |
| Device Manufacturer Date | 2000-01-01 |
| Date Added to Maude | 2005-05-03 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. GREG SREDIN |
| Manufacturer Street | 2925 APPLING RD. |
| Manufacturer City | BARTLETT TN 38133 |
| Manufacturer Country | US |
| Manufacturer Postal | 38133 |
| Manufacturer Phone | * |
| Manufacturer G1 | GYRUS ENT |
| Manufacturer Street | 2925 APPLING RD |
| Manufacturer City | BARLETT 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 | RICHARDS HAPEX OFFSET MALLCABLE PORP |
| Generic Name | PARTIAL OSSICULAR REPLACEMENT PROSTHESIS |
| Product Code | ETB |
| Date Received | 2005-05-02 |
| Model Number | NA |
| Catalog Number | 70145892 |
| Lot Number | 0015761889 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 2.5 MO |
| Device Eval'ed by Mfgr | N |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 587701 |
| Manufacturer | GYRUS ENT |
| Manufacturer Address | * BARTLETT TN 38133 US |
| Baseline Brand Name | RICHARDS HAPEX OFFSET MALLEABLE PORP |
| Baseline Generic Name | PORP |
| Baseline Model No | NA |
| Baseline Catalog No | 70145892 |
| Baseline ID | NA |
| Baseline Device Family | PARTIAL OSSICULAR REPLACEMENT PROSTHESES |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K950886 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2005-05-02 |