MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP - NORTHFIELD SKIN AFFIX; TAPE AND BANDAGE, ADHESIVE

Lot Number P00228685

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Rash (2033)

Event Date 04/18/2023

Event Type  Injury  

Event Description

Pt underwent an excision of a right breast mass on (b)(6) 2023 - skin affix applied to surgical incision; pt noted with redness to surgical site, rash noted from axilla to mid arm on f/u visit on (b)(6) 2023.Pt to be treated with antibiotics and benadryl.

• Brand Name: SKIN AFFIX
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP - NORTHFIELD
• MDR Report Key: 16940648
• MDR Text Key: 315370822
• Report Number: MW5117561
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 05/11/2023

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: Health Professional
• Device Lot Number: P00228685
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/15/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR
• Patient Sex: Female
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White