MAUDE Adverse Event Report: MCKESSON MEDICAL-SURGICAL INC XEROFORM DRESSING; DRESSING, WOUND, DRUG

Lot Number	09237
Health Effect - Clinical Codes	Itching Sensation (1943); Blister (4537); Skin Burning Sensation (4540); Skin Inflammation/ Irritation (4545)
Date of Event	01/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Had surgery for baxter's nerve release.Xeroform dressing was applied to surgical site on (b)(6) 2025.One week later it resulted in a rash in the area the xeroform dressing was applied.The rash blistered.Felt like burning and had uncontrollable itching.Diphenhydramine was used with little to no effect.Ice applied to the area to reduce burning feeling and distract from itching.No tests were performed.Evaluation done by pa when dressings were removed.

• Brand Name: XEROFORM DRESSING
• Common Device Name: DRESSING, WOUND, DRUG
• Manufacturer (Section D): MCKESSON MEDICAL-SURGICAL INC; 9954 mayland drive; richmond VA 23233
• MDR Report Key: 21422163
• Report Number: MW5166541
• Device Sequence Number: 4209952
• Product Code: FRO
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 02/14/2025

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?: Yes
• Device Lot Number: 09237
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/20/2025
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ACETAMINOPHEN; IBUPROFEN
• Patient Age: 1 MO
• Patient Sex: Female
• Patient Weight: 116 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White