InjuryOGQ
Q-GRIP
Received May 14, 2020 · Event occurred May 13, 2020
Report MW5094519 · MDR key 10061459
Device
Generic name
Ear Irrigation Kit
Manufacturer
UnkProduct problems
- Adverse Event Without Identified Device or Use Problem
Patient
33 YR
- Hearing Loss
- Tissue Damage
- Hearing Loss
- Tissue Damage
Narrative
Description of Event or Problem
HI, I USED THIS PRODUCT AND IT DAMAGED/SCRATCHED MY EARDRUM. I COULDN'T HEAR FOR A FEW DAYS AFTER USING IT. SAW MY DOCTOR WHO PRESCRIBED REST AND QUIET SOUNDS. IT DOESN'T SEEM TO BE FDA APPROVED FOR TREATMENT EVEN THOUGH IT CLAIMS TO BE. (B)(4). MY MD SAID I SCRATCHED BUT DIDN'T PERFORATE MY EARDRUM. THIS PRODUCT SHOULD BE ILLEGAL, PERIOD. (B)(4). FDA SAFETY REPORT ID# (B)(4).