FDA Adverse Event Injury Summary report: N

MICROSUCTION VACUUM

MDR report key: 16833078 · Received April 27, 2023

Report

Report Number
MW5117125
Event Type
Injury
Date Received
April 27, 2023
Date of Event
March 28, 2023
Report Date
April 24, 2023
Manufacturer
UNK
Product Code
LRD
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
VA, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

ON (B)(6) 2023 MY PCP(PRIMARY CARE PROVIDER), DR.(B)(6) PERFORMED A PHYSICAL FOR A PRESURGICAL EVALUATION. I MENTIONED THAT, SINCE BEEN TREATED FOR A MILD EAR INFECTION WITH ANTIBIOTICS SEVERAL MONTHS EARLIER, I HAD BEEN NOTICING SOME SENSATION OF FULLNESS IN MY EAR AND WOKE UP FEELING LIKE SOUND WAS MUFFLED. SHE EXAMINED MY EARS AND DIAGNOSED IMPACTED CERUMEN AND REFERRED ME TO AN ENT(OTOLARYNGOLOGIST), DR. (B)(6). ON (B)(6) 2023 HE REMOVED THE EARWAX WITH A MICROSUCTION VACUUM. AS SOON AS HE WAS FINISHED I COULD NOT HEAR HIM, THE RECEPTIONIST OR THE CAR RADIO. I RETURNED LATER THAT DAY AND HE TOLD ME THAT EVERYTHING LOOKED FINE AND THAT I NEEDED A HEARING TEST. HE HAD NO EXPLANATION AS TO WHY I SUDDENLY LOST MY HEARING. BEFORE THIS DATE, I HAD NEVER NEEDED A HEARING TEST SINCE I WAS ABLE WITH RARE EXCEPTION TO FOLLOW CONVERSATION AND GENERATED COMPUTER VOICES IN A LANGUAGE APP. I SET UP THE APPOINTMENT AND WAS FOUND TO HAVE MODERATE TO SEVERE HEARING LOSS IN BOTH EARS AND NOW REQUIRE HEARING AIDS. HIS NOTE INDICATES BILATERAL, SENSORINEURAL HEARING LOSS. I CAN TALK ON THE PHONE ONLY WITH A SPEAKER AND USING A BORROWED HEARING AID. I CAN NOT ACCURATELY HEAR CONVERSATION EVEN FROM ONE PERSON WITHOUT BACKGROUND NOISE. I CANNOT HEAR THE RADIO OR THE COMPUTER. THIS TEST WAS PERFORMED BY (B)(6) HEARING HEALTH ASSOCIATES. MICROSUCTION DR. HAS THE DEVICE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
627761 MICROSUCTION VACUUM APPLICATOR, ENT DRUG LRD UNK

Patients

Seq Age Sex Outcome Treatment
1 72 YR Female Disability CALCIUM | CHLORTHALIDONE| LEVOTHYROXINE| LISINOPRIL| METHOTREXATE| MULTIVITAMIN| ROSUVASTATIN| VITAMIN C | VITAMIN D