MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-04-15 for SAFHS SONIC ACCELERATED FRACTURE HEALING SYSTEM manufactured by Exogen, Inc..
[20769856]
Defective bridge rectifier. The pt was sent a replacement system. The problem has been addressed through the use of a glass passivated, full wave bridge rectifier in the main operating unit (mou). This unit was built prior to implementation of this corrective action. No failures have occurred with the new brdige rectifiers.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5000017 |
| MDR Report Key | 34173 |
| Date Received | 1996-04-15 |
| Date of Report | 1996-04-12 |
| Date Added to Maude | 1996-07-19 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SAFHS SONIC ACCELERATED FRACTURE HEALING SYSTEM |
| Generic Name | FRACTURE HEALING SYSTEM |
| Product Code | LPQ |
| Date Received | 1996-04-15 |
| ID Number | P900009 |
| Operator | OTHER |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 35533 |
| Manufacturer | EXOGEN, INC. |
| Manufacturer Address | 10 CONSTITUTION AVE PO BOX 6860 PISCATAWAY NJ 08855 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-04-15 |