MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-22 for AU20790 manufactured by Avalign German Specialty Instruments.
[83531135]
The broken tip was not included with the broken device for investigation. The material and hardening of the device is like intended per the dhr review.
Patient Sequence No: 1, Text Type: N, H10
[83531136]
Customer reported their sales rep reported via email instrument that broke during a case on (b)(6) 2017. The instrument broke inside a patient and the broken piece could not be retrieved due to potential risk of hearing loss upon removal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1421101-2017-00002 |
| MDR Report Key | 6810898 |
| Date Received | 2017-08-22 |
| Date of Report | 2017-06-12 |
| Date Mfgr Received | 2017-05-16 |
| Date Added to Maude | 2017-08-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JENNIFER STAUNTON |
| Manufacturer Street | 626 COOPER COURT |
| Manufacturer City | SCHAUMBURG IL 60173 |
| Manufacturer Country | US |
| Manufacturer Postal | 60173 |
| Manufacturer Phone | 8479080292 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Generic Name | STAPEDECTOMY PICK |
| Product Code | JYT |
| Date Received | 2017-08-22 |
| Returned To Mfg | 2017-05-19 |
| Catalog Number | AU20790 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AVALIGN GERMAN SPECIALTY INSTRUMENTS |
| Manufacturer Address | 626 COOPER COURT SCHAUMBURG IL 60173 US 60173 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-22 |