OCWAX BLASTER MD
Received Nov 13, 2020 · Event occurred Oct 5, 2020
Report 3013559620-2020-00001 · MDR key 10837438
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
5 YR
- Rupture
- Rupture
Narrative
Additional Manufacturer Narrative
EAR SYRINGING IS A COMMON CLINICAL PROCEDURE IN PRIMARY HEALTH CARE AND THERE ARE MANY 'AT-HOME' SYRINGES AVAILABLE. IN THIS CASE, THE CUSTOMER STATED THAT HIS DOCTORS OFFICE RECOMMENDED THAT HE PURCHASE AN EAR IRRIGATING DEVICE TO USE AT HOME. WE HAVE NOT BEEN SUCCESSFUL IN OBTAINING ANY OTHER ADDITIONAL INFORMATION FROM THE CUSTOMER ON THE EVENT AFTER 3 ATTEMPTS. WE HAVE HAD NO OTHER REPORTABLE COMPLAINTS ON THIS PRODUCT. THE DATE OF THIS REPORT IS PAST THE 30 DAY REQUIREMENT. DURING OUR ATTEMPT TO GET FULL PRODUCTION ACCESS TO WEBTRADER.COM, WE FOUND OUT THAT WEBTRADER DOES NOT SUPPORT (B)(6) COMPUTERS, WHICH WAS OUR PRIMARY PLATFORM. IT TOOK ADDITIONAL TIME FOR US TO GAIN ACCESS TO A PC. TODAY (11/13/2020) WE RECEIVED FULL PRODUCTION ACCESS FROM THE ESG HELPDESK TEAM. OUT OF ABUNDANCE OF CAUTION, WE PHYSICALLY MAILED THE FORM 3500A TO THE FOLLOWING ADDRESS ON 11/5/2020: (B)(6).
Description of Event or Problem
FATHER USED EAR RINSE DEVICE ON SON TO CLEAR EAR CANAL AS DIRECTED BY THEIR PHYSICIAN. FATHER REPORTED THAT THE EAR DRUM RUPTURED DURING USE. THE NEXT DAY HE TOOK THE CHILD TO URGENT CARE AND THE CHILD HAD A RUPTURED EAR DRUM CONFIRMED BY URGENT CARE DOCTOR.