MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-28 for SIEMENS HEARING AID SIVANTOS/SIEMENS PURE 7MI RIC R manufactured by Siemens/ Signia/ Sivantos.
[93197516]
Broken tip of hearing aid on the right got stuck in the right eac and had to be mechanically retrieved. This is the device as listed by audiology: (b)(6) 2014 sivantos/siemens pure 7mi ric right sn: (b)(4) (b)(6) 2016 (b)(6) 2014 sivantos/siemens pure 7mi ric. Left sn: (b)(4) (b)(6) 2016.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5073578 |
| MDR Report Key | 7063396 |
| Date Received | 2017-11-28 |
| Date of Report | 2017-11-24 |
| Date of Event | 2017-11-24 |
| Date Added to Maude | 2017-11-28 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 0 |
| Brand Name | SIEMENS HEARING AID |
| Generic Name | HEARING AID |
| Product Code | ESD |
| Date Received | 2017-11-28 |
| Model Number | SIVANTOS/SIEMENS PURE 7MI RIC R |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS/ SIGNIA/ SIVANTOS |
| Brand Name | SIEMENS HEARING AID |
| Generic Name | HEARING AID |
| Product Code | ESD |
| Date Received | 2017-11-28 |
| Model Number | SIVANTOS/SIEMENS PURE 7MI RIC R |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-11-28 |