COTTON SWABS B0175

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-05 for COTTON SWABS B0175 manufactured by Unk.

Event Text Entries

[110490022] I purchased "dg body plastic stick cotton swabs," from my local (b)(6) store on (b)(6). Shortly thereafter i was attempting to clean my ears with these swabs, and the cotton "ball" attached to the plastic came unglued and remains now detached and lodged inside my ear canal. I am shortly going to seek medical attention to have it removed. These swabs obviously should have glue that is substantial enough to prevent their becoming detached, which led to the problem, and i believe is a medical mfg defect. At 12:15 pm (b)(6) 2018, just now someone from the (b)(6) risk mgmt office just hung up on me. They refused to even discuss the problem with me. They apparently believe that (b)(6) doesn't have a responsibility to respond to medical emergencies or other issues related to their medical products. This is at 1:27 pm monday on (b)(6) 2018. Now i'm talking to (b)(6) in customer service x5121 (b)(6) is her manager. She says she's going to transfer me to her manager. They might be able to help me. Got a message from her and waiting for anyone to call me back. They said they "don't have a report" about my situation at (b)(6), this is at 1:35 pm, now making another call: now at 1:42 pm on hold with (b)(6) risk mgmt group trying to get a response. They are not responding, have me on hold. (b)(6), rep from risk mgmt and customer service insulted me and talked to me in a very "flippany" manner and treated me like a third class citizen on the call, even though he knew that they had an issue here; he repeated that "we have no liability and we tell you on the packaging "do not stick these in your ears," and when i told him that wasn't true, he denied it and refused to allow me to send him a picture of the packaging. I could go on, we hung up the second time at about 1:55 pm (b)(6) 2018. I am confident that (b)(6) neither cares nor has any interest in helping me sincerely. He is an arrogant corporate solder from a company that has a very lackadaisical attitude toward their customers and their liabilities.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5077665
• MDR Report Key: 7573067
• Date Received: 2018-06-05
• Date of Report: 2018-06-04
• Date of Event: 2018-06-04
• Date Added to Maude: 2018-06-06
• 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: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: COTTON SWABS
• Generic Name: ABSORBENT TIPPED
• Product Code: KXF
• Date Received: 2018-06-05
• Model Number: B0175
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: UNK
• Manufacturer Address: UNK UNK

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other; 2. Required No Informationntervention	2018-06-05