MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; RX ADV AB W/P XL H/DUTY 10CT

Catalog Number DG00462402

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 07/02/2023

Event Type  Injury  

Event Description

According to the customer on (b)(6) 2023, the user experienced a reaction from the bandage that was described as swelling and redness to their arm.

Manufacturer Narrative

According to the customer on (b)(6) 2023 the user experienced a reaction from the bandage that was described as swelling and redness to their arm.Per the customer they did not use ointments, lotions prior to using the bandage.Per the customer the reaction occurred within a few hours after the bandage was applied to "clean skin".Per the customer the user was prescribed mupirocin 2% three times a day.Per the customer the users skin is still raw and being treated.Sample requested to be returned for evaluation.No additional information is available at this time.It has been determined that the reported event caused or contributed to serious injury requiring medical intervention, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Type of Device: RX ADV AB W/P XL H/DUTY 10CT
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 17390146
• MDR Text Key: 319766832
• Report Number: 1417592-2023-00313
• 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: 07/25/2023

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: DG00462402
• Device Lot Number: 220701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2023
• Initial Date Manufacturer Received: 07/06/2023
• Initial Date FDA Received: 07/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other