MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-07 for DRIVE UNKNOWN manufactured by Unknown.
[79313382]
Drive devilbiss is the initial importer of the device. We have attempted to get the device returned and additional information from the enduser. Drive received fax notification of the incident from healthcare provider. The enduser, who suffered a stroke, was using the device which was identified only as a trapeze. The enduser alleges that the s hook broke and the bar swung at his face causing a tooth to break.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2438477-2017-00057 |
| MDR Report Key | 6694569 |
| Date Received | 2017-07-07 |
| Date of Report | 2017-06-07 |
| Date of Event | 2017-03-27 |
| Report Date | 2017-07-06 |
| Date Reported to FDA | 2017-07-06 |
| Date Added to Maude | 2017-07-07 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRIVE |
| Generic Name | AID, TRANSFER |
| Product Code | IKX |
| Date Received | 2017-07-07 |
| Model Number | UNKNOWN |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNKNOWN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-07-07 |