MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; BANDAGE, ADHESIVE, WTRPRF, 1"X3", ST, LF

Catalog Number NON25670

Device Problem Chemical Problem (2893)

Patient Problems Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Skin Inflammation/ Irritation (4545)

Event Date 05/30/2023

Event Type  Injury  

Manufacturer Narrative

According to the customer, she was using the bandage to over a "biopsy" site on her arm and the skin where the adhesive was located became "red and itchy".The customer reported when she went to her follow up appointment for the biopsy, the physician assessed the skin and stated she was "allergic to the adhesive and the skin is infected".The customer reported the physician prescribed her "doxycycline" antibiotic pills.No additional information is available at this time.It has been determined that the reported event caused or contributed to serious injury, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

According to the customer, she was using the bandage to over a "biopsy" site on her arm and the skin where the adhesive was located became "red and itchy".

• Type of Device: BANDAGE, ADHESIVE, WTRPRF, 1"X3", ST, LF
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 17209816
• MDR Text Key: 317942580
• Report Number: 1417592-2023-00265
• 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: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: NON25670
• Device Lot Number: 220202
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other