MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-05-11 for TREATMENT HEAD MODULE manufactured by Exogen,inc..
[16296653]
A replacement unit was sent to the pt on 2/27/95 in a priority overnight shipment. Upon return of the device in question, it was noted that the transducer cup assembly had broken loose from the transducer barrel. The adhesive which bonds the transducer cup to the barrel had not bonded as expected. The contract mfr had been notified of this possibility prior to this occurrence and has taken appropriate steps to prevent this from recurring.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5000007 |
| MDR Report Key | 22395 |
| Date Received | 1995-05-11 |
| Date of Report | 1995-05-02 |
| Date Added to Maude | 1995-06-13 |
| 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 | TREATMENT HEAD MODULE |
| Generic Name | TREATMENT HEAD MODULE |
| Product Code | LPQ |
| Date Received | 1995-05-11 |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 22541 |
| Manufacturer | EXOGEN,INC. |
| Manufacturer Address | PISCATAWAY NJ 08855 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1995-05-11 |