MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-02-28 for PROSONIC CLEANSING AND EXFOLIATION SYSTEM, STANDARD manufactured by Ora.
[20001521]
I recently purchased a prosonic cleansing and exfoliating system from (b)(6) on (b)(6) 2012. I have used the product approx 4-5/weeks. On (b)(6) 2013, i was approx 15 seconds into the scrubbing process. I was holding the exfoliator with my left hand and was scrubbing my left cheek bone and bam. The product exploded in my hand. I immediately dropped the product and had an intense ringing in my left ear that last for approx 30 minutes. I am continuing to have inner ear pain. Upon inspecting the product at a later time, i believe that something blew-up on the inside and forced an explosion that ruptured the rubber exterior buttons to cause the loud explosion. I have researched this on-line and have noticed similar complaints. I have used this product as instructed and did not have it for a lengthy period of time. I believe this product to have a pattern of these explosions. Dates of use: (b)(6) 2012 - (b)(6) 2013.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5029275 |
| MDR Report Key | 2999525 |
| Date Received | 2013-02-28 |
| Date of Report | 2013-02-28 |
| Date of Event | 2013-02-26 |
| Date Added to Maude | 2013-03-12 |
| 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 | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROSONIC CLEANSING AND EXFOLIATION SYSTEM, STANDARD |
| Generic Name | CLEANSING AND EXFOLIATION SYSTEM |
| Product Code | GFE |
| Date Received | 2013-02-28 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORA |
| Manufacturer Address | LOS ANGELES CA 91364 US 91364 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-02-28 |