WALGREENS EAR PLUGS -SILICONE- FLENTS #906 NONE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-11-18 for WALGREENS EAR PLUGS -SILICONE- FLENTS #906 NONE manufactured by Flents Products Co..

Event Text Entries

[286417] After using the earplugs as directed on the package, pt woke up with a large portion of the plug broken away, but a part of the plug had gotten into the ear canal and worked its way toward the eardrum through a night of sleeping. Pt found the large portion, but realized there was about a pea-sized part missing. They felt the tip sticking out of their ear, and went to the m. D. The next day, who said she could not handle it. Pt was sent to the medical school, where an ent specialist had to scrape and suction for 20 excruciating minutes to get the piece out of pt's ear. Pt now will be treated with antibiotics and steriods for possible infection and inflammation, and return for a hearing exam in a week. The ent made the statement he had done surgery that was easier than this procedure. The product seems to change when subjected to body heat, and tends to crumble, even though it was only the second time pt had used these particular plugs, which are noted to be reusable on the box. Pt does not want anyone to have to endure the painful procedure they went through. Both the nurse and doctor said these feel more like gooey candle wax that breaks apart, than a silicone product.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1026776
• MDR Report Key: 428766
• Date Received: 2002-11-18
• Date of Report: 2002-11-18
• Date of Event: 2002-10-18
• Date Added to Maude: 2002-11-25
• 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
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: WALGREENS EAR PLUGS -SILICONE-
• Generic Name: SILICONE EAR PLUGS
• Product Code: EWD
• Date Received: 2002-11-18
• Model Number: FLENTS #906
• Catalog Number: NONE
• Lot Number: NONE
• ID Number: NONE
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 417790
• Manufacturer: FLENTS PRODUCTS CO.
• Manufacturer Address: * ST. CHARLES MI 48655 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2002-11-18