MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-07-19 for SAFHS manufactured by Exogen, Inc..
[21078]
A device failure was reported on 5/9/95. A replacement unit was sent to the pt on the same day in a priority overnight shipment. It was reported that the system would not stop operation after the 20 min cycle and that one of the fiber optic cables was slipping out of the connector. Upon return of the unit, it was found that pt had never depressed the "treatment start" switch. The fiber optic cable was traced to a loose collar band which allowed the cable to slip out of the connector. This is the first time a problem of this type has been encountered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5000013 |
| MDR Report Key | 28792 |
| Date Received | 1995-07-19 |
| Date of Report | 1995-07-18 |
| Date of Event | 1995-05-09 |
| Date Added to Maude | 1995-12-19 |
| 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 |
| Generic Name | FRACTURE HEALING SYSTEM |
| Product Code | LPQ |
| Date Received | 1995-07-19 |
| ID Number | P90009/RC3U1 |
| Operator | OTHER |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 29759 |
| Manufacturer | EXOGEN, INC. |
| Manufacturer Address | 10 CONSTITUTION AVE PISCATAWAY NJ 08855 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1995-07-19 |