OTO-EASE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-08-03 for OTO-EASE manufactured by .

Event Text Entries

[2782489] On (b)(6) 2012, says the aids are not loud enough. Re-programmed with experience level turned from 2 to 4. Cleaned. Says they sound good. Gave him a bottle of oto-ease at his request. Molds go in easily without it. Cerumen starting to build up in his ears. Discussed use of h-peroxide and discontinue use of q-tips. On (b)(6) 2012, received recall info on product via email fda recall. Pt was notified of recall and that he should throw product away. He indicated he understood. On (b)(6) 2012, he called back today and said he had used the oto-ease and had gotten an ear infection. He is being treated by an md. On (b)(6) 2012, pt was notified that he needed to be seen by our md appointment scheduled per his requested on (b)(6) 2012, with ent. On (b)(6) 2012, pt called to saw he had canceled ent appointment since he had seen his provider today and was treated for "black fungus" in his ear.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5026410
• MDR Report Key: 2688485
• Date Received: 2012-08-03
• Date of Report: 2012-08-03
• Date of Event: 2012-07-20
• Date Added to Maude: 2012-08-13
• 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
• 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

Device Details

• Brand Name: OTO-EASE
• Generic Name: NONE
• Product Code: EWD
• Date Received: 2012-08-03
• Lot Number: LOTPBWT
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2012-08-03