MAUDE Adverse Event Report: UNKNOWN RITEAID SHEER ADHESIVE PADS 2 X 3.75" (5.1 X 9.5CM) ; BANDAGE, ELASTIC, BANDAIDS ADHESIVE

Catalog Number RA398569R

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Erythema (1840)

Event Date 01/15/2019

Event Type  Injury  

Event Description

A biopsy of skin neoplasm on lower left leg on (b)(6) 2019.Bandage caused rather severe erythema from the adhesive parts of the pads which persists after removing the bandage ((b)(6)] sheer adhesive pads 2x3.75¿ item #398569.I have photographs of the injury as of 8.15 am (b)(6) 2019.

• Brand Name: RITEAID SHEER ADHESIVE PADS 2 X 3.75" (5.1 X 9.5CM)
• Type of Device: BANDAGE, ELASTIC, BANDAIDS ADHESIVE
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 8343990
• MDR Text Key: 137169802
• Report Number: MW5084143
• Device Sequence Number: 1
• Product Code: FQM
• UDI-Device Identifier: 01182208569
• UDI-Public: 01182208569
• 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: 02/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: RA398569R
• Device Lot Number: 17114
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/14/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 84 YR