MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-09-27 for SAFHS manufactured by Exogen, Inc..
[17504]
On 8/8/95 a pt informed the co she experienced an "aching" at the site of treatment. She had been shipped a unit on 6/28/95. Repeated attempts were made to contact the pt without success. On 8/22/95 she called to state that she was returning the device on her dr's instructions due to her complaints of pain at the treatment site. Her physician confirmed this on the same date. Upon receipt of the unit, it was found that the pt had not been compliant in using the device and had, in fact, only used it for two days in august. Thus it cannot be determined if this complaint was device-related.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5000010 |
| MDR Report Key | 28790 |
| Date Received | 1995-09-27 |
| Date of Report | 1995-09-26 |
| Date of Event | 1995-08-08 |
| 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 | 1995-09-27 |
| ID Number | P900009/RC3U1 |
| Operator | OTHER |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 29757 |
| Manufacturer | EXOGEN, INC. |
| Manufacturer Address | 10 CONSTITUTION AVE PO BOX 6860 PISCATAWAY NJ 08855 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1995-09-27 |