MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2016-09-22 for PHONAK VIRTO V70 PHONAK VIRTRO V70 manufactured by Phonak Ag.
[55366149]
The standard manufacturing process and material were applied within the production of the shell. The risk of a broken shell was integrated into risk management file in june 2015. Shell broke due to the no appropriate force from outside. Accident with the patient: patient fell and crashed with his right ear against a hard wall. Based on the patient's information, he was already medically cleared to wear the hearing aid device again. Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[55366150]
(b)(6) 2016 reported that customer in (b)(6) had an accident. He fell onto his head and hit a hard wall with his right ear. He had outside injuries and his ite crushed and broke into sharp shell splitters in his ear canal. Shell fragments caused injuries of eardrum and inner ear canal. The patient has been injured by the wall on his face near his ear and by shell splitter in the ear canal. " i kept permanent damages as this "intra's explosion" decreased my hearing of 5 db, the eardrum made a new skin, so the old one has to be sucked by the hears specialist i saw. I have still struggling at the bottom but we do not know from where it is, so the conclusion is that the "air pressure" of the intra explosion caused visible external injuries (per doctor first aid report ) and internal not visible trauma injuries, as well as the razor blades made deep multi cuts in the external meatus. " note: the doctors report is in (b)(6) and not included.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005085999-2016-00001 |
| MDR Report Key | 5969888 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2016-09-22 |
| Date of Report | 2016-03-11 |
| Date of Event | 2016-01-01 |
| Date Mfgr Received | 2016-03-11 |
| Date Added to Maude | 2016-09-22 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | VALENTINA SHCHERBA |
| Manufacturer Street | LAUBISRUTISTRASSE 28 |
| Manufacturer City | STAFA, CH-8712 |
| Manufacturer Country | SZ |
| Manufacturer Postal | CH-8712 |
| Manufacturer Phone | 280101 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PHONAK VIRTO V70 |
| Generic Name | PHONAK VIRTO V70 (ITE/CUSTOM) |
| Product Code | OSM |
| Date Received | 2016-09-22 |
| Model Number | PHONAK VIRTRO V70 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHONAK AG |
| Manufacturer Address | LAUBISRUTISTRASSE 28 STAFA, CH-8712 SZ CH-8712 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-09-22 |