MAUDE Adverse Event Report: SHEER STRIPS; TAPE AND BANDAGE, ADHESIVE

Model Number EXTRA LARGE

Device Problem Material Integrity Problem (2978)

Patient Problem Insufficient Information (4580)

Event Date 02/09/2022

Event Type  malfunction  

Event Description

Cover on adhesive defective; equaline [(b)(4)] sheer strips xl adhesive bandages.Covers on gauze part do not strip away.Crumbles into pieces which adhere to the adhesive parts.Not suitable for the intended use as a class 1 medical device.Upc 0 41163 24468 9 equaline, bought from osco in (b)(6) in 2021.(b)(6) is a child of parent (b)(4).Box of 10 "sheer strips" states, "we are committed to your satisfaction and guarantee the quality of this product.Contact us at (b)(4), or www.Albertsons.Com.Violation of section 502 fd&c act section 502 misbranding.Distributed by (b)(4).Fda safety report id #:(b)(4).

• Brand Name: SHEER STRIPS
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• MDR Report Key: 13542060
• MDR Text Key: 285744013
• Report Number: MW5107470
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: EXTRA LARGE
• Device Catalogue Number: ADHESIVE BANDAGES
• Device Lot Number: 243125
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/15/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White