MAUDE Adverse Event Report: UNKNOWN BUTTERFLY CLOSURES; TAPE AND BANDAGE, ADHESIVE

Model Number 245071557R01

Device Problem Product Quality Problem (1506)

Patient Problems Abscess (1690); Swelling (2091); Reaction (2414)

Event Date 07/04/2020

Event Type  Injury  

Event Description

Had problems after switching from one product maker to another maker: yes.(b)(6) brand (b)(6) butterfly closure idc (b)(4).Lot 20104.After 24 hours, large blister formed under right wing of bandage adhesive.Two small open abscess wounds formed under left side of bandage adhesive.Had previously been using (b)(6) brand for 2 weeks with no issues.I have never had an adhesive reaction in (b)(6) years of using band-aid-type products.Treating antibiotics ointment, adhesive induced wounds are located near surgical incision site.Fda safety report id #: (b)(4).

• Brand Name: BUTTERFLY CLOSURES
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 10245180
• MDR Text Key: 198204477
• Report Number: MW5095423
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 00045001037
• UDI-Public: 00045001037
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 245071557R01
• Device Lot Number: 20104
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Weight: 54