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..
[22190015]
A possible sensitivity reaction which was first reported to co on 2/26/96. The pt complained of an aching pain in the wrist during treatment. He discontinued use of the device after two treatments. The device was returned to co on 3/18/96 for a complete check. The system was found to be operating within the prescribed parameters. A report was sent to his physician.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5000019 |
| MDR Report Key | 34176 |
| 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 | 35536 |
| 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 |