MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-02-28 for SAFHS SONIC ACCELERATED FRACTURE HEALING SYSTEM manufactured by Exogen, Inc..
[18528]
A device failure was reported on 2/10/95. A replacement unit was sent to the pt on the same day in a priority overnight shipment. Upon return of the failed unit, visual inspection revealed that the transducer element had separated from the transducer cup. This caused one of the transducer internal connections to separate. This problem caused the main operating unit (mou) to stop operating and activated the trouble alarm as the system was designed to do. The transducer has been returned to the mfr for evaluation of this problem. This is an isolated incident and no action will be instituted at the present time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5000020 |
| MDR Report Key | 34175 |
| Date Received | 1995-02-28 |
| Date of Report | 1995-02-23 |
| 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 | 1995-02-28 |
| ID Number | P900009 |
| Operator | OTHER |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 35535 |
| Manufacturer | EXOGEN, INC. |
| Manufacturer Address | 810 PASSAIC AVE WEST CALDWELL NJ 07006 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1995-02-28 |