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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNILEVER Q-TIP

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UNILEVER Q-TIP Back to Search Results
Device Problem Detachment Of Device Component (1104)
Patient Problems Hearing Impairment (1881); Pain (1994); Foreign Body In Patient (2687)
Event Date 01/26/2012
Event Type  Injury  
Event Description

The consumer says that he used the q-tip and the cotton separated from the stem. He went to a hearing aid specialist and a scope test found that he had cotton in his ear. He says that it attributed to his hearing problem and the pain in his ear. The consumer said he called the mfr and left a message last week and again today. They have yet to return his call. Document number: (b)(4). Retailer: renders supermarket. Purchase date: (b)(6) 2012: this date is an estimate. The product was not damaged before the incident. The product was not modified before the incident.

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Brand NameQ-TIP
Type of DeviceQ-TIP
Manufacturer (Section D)
MDR Report Key2465618
MDR Text Key17974321
Report NumberMW5024309
Device Sequence Number1
Product Code KXF
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 02/09/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/09/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator OTHER
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No