MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-19 for THE BRIDGE EAR DEVICE FOR OPIOD WITHDRAWAL manufactured by Unk.
[103003718]
Pt given the "bridge device" for opioid withdrawal with no evidence of efficacy, and then left real treatment due to "i have the bridge. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5075971 |
| MDR Report Key | 7352342 |
| Date Received | 2018-03-19 |
| Date of Report | 2018-03-17 |
| Date of Event | 2018-02-20 |
| Date Added to Maude | 2018-03-20 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| 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 | 0 |
| Brand Name | THE BRIDGE EAR DEVICE FOR OPIOD WITHDRAWAL |
| Generic Name | STIMULATOR, ELECTRO-ACUPUNCTURE |
| Product Code | BWK |
| Date Received | 2018-03-19 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-03-19 |