MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-09-22 for PHONAK VIRTO Q90-312 (M) PHONAK VIRTO Q90-312M manufactured by Phonak Llc.
[55371300]
The case is a single isolated event and has to be detailed evaluated based on the device inspection. Without the device evaluation, it is not possible to say if it was a problem with the device, device misuse, or what could have caused such device behavior. Similar received cases about overheating showed indication of misuse or use of the wrong battery or incorrect use of the battery. Based on the patient's information, (he was already medically cleared to wear the hearing aid device again). It means that the case is not life threatening. Does not result in permanent impairment of a body function or permanent damage to a body structure, or patient needed medical intervention but not to preclude permanent impairment of a body function or permanent damage to a body structure. In current status of the case - there is no reasonable probability that use of or exposure to the device will cause serious adverse health consequences or death; or that use of or exposure to the device may cause temporary or medically irreversible adverse health consequences or an outcome where the probability of serious adverse health consequences is remote. Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[55371301]
(b)(6) 2016 audiologist called phonak to inform us that her patient called to notify her that while driving recently, he begin to hear a boiling sound in his ear occurring from this device soon after the device exploded in his ear and patient has second degree burns. Since then the patient has been receiving treatment from his doctor. Audiologist wanted to inform phonak of the incident. Clinical follow up performed on 7/27/2016 -audiologist indicated that patient reported the incident happened in (b)(6)--changed battery that day. Was in car at stop light and heard a sound and felt heat and burning sensation. Removed hearing instrument quickly and it was hot to touch, let it drop to ground. Had 2nd degree burn in ear canal. Was seeing physician. He now has been medically cleared to wear device again. Patient will bring device to audiologist to send in to phonak. Clinical follow up performed on 7/28/2016 - requested medical assessment/records from physician related to this incident reported by patient. However, audiologist could not release the medical records from his physician due to patient confidentiality. Another attempt to get the device back was made on 8/1/2016 and audiologist informed that patient is on vacation for 2-4 weeks and patient is informed that once he returns from his vacation, he needs to send the device back for analysis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1421524-2016-00001 |
| MDR Report Key | 5970425 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-09-22 |
| Date of Report | 2016-07-15 |
| Date of Event | 2016-06-01 |
| Date Mfgr Received | 2016-07-15 |
| Device Manufacturer Date | 2014-05-23 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BENITA DU RANDT |
| Manufacturer Street | 4520 WEAVER PARKWAY |
| Manufacturer City | WARRENVILLE IL 60555 |
| Manufacturer Country | US |
| Manufacturer Postal | 60555 |
| Manufacturer Phone | 6308215000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PHONAK VIRTO Q90-312 (M) |
| Generic Name | PHONAK VIRTO Q (ITE/CUSTOM) |
| Product Code | OSM |
| Date Received | 2016-09-22 |
| Model Number | PHONAK VIRTO Q90-312M |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHONAK LLC |
| Manufacturer Address | 4520 WEAVER PARKWAY WARRENVILLE IL 60555 US 60555 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-09-22 |