MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-01 for U - TUBE manufactured by Unk.
[61511282]
On (b)(6) 2015, surgery: u - tube, on (b)(6) 2016 to (b)(6) 2016 and previous years at various hospitals in (b)6). I did not authorize doctor to know that dr (b)(6) did that to me on (b)(6) 2015. I want justice and restitution for this unnecessary device in my left ear (middle ear). I live in constant pain and my hearing is a mess. Procedure performed: left tympanostomy with tube insertion. Dr (b)(6). Haloperidol by mouth and injection. U-tube all infected, etc, etc. Bad side effects from haldol - haloperidol.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5066529 |
| MDR Report Key | 6145248 |
| Date Received | 2016-12-01 |
| Date of Report | 2016-11-26 |
| Date of Event | 2015-02-03 |
| Date Added to Maude | 2016-12-05 |
| 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 | 3 |
| Reporter Occupation | PATIENT |
| 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 | U - TUBE |
| Generic Name | TUBE TYMPANOSTOMY |
| Product Code | ETD |
| Date Received | 2016-12-01 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Other; 4. Required No Informationntervention | 2016-12-01 |