MAUDE Adverse Event Report: MEDLINE INDUSTRIES CURAD XEROFORM PETROLATUM DRESSING; DRESSING, WOUND, DRUG

Model Number	CUR253200
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/07/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Xeroform petrolatum dressing was opened onto the sterile field.Surgeon noted that the product appeared to be very dry with a different feel than what is typical for this product.Another dressing with the same lot number was opened with the same issues.A third dressing with a different lot number was opened, and it was the typical moisture level and feel for the product.

• Brand Name: CURAD XEROFORM PETROLATUM DRESSING
• Common Device Name: DRESSING, WOUND, DRUG
• Manufacturer (Section D): MEDLINE INDUSTRIES; mundelein IL 60060
• MDR Report Key: 6791409
• Report Number: MW5071542
• Device Sequence Number: 13478006
• Product Code: FRO
• UDI-Device Identifier: 10884389160367
• UDI-Public: (01)10884389160367
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/10/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 11/30/2019
• Device Model Number: CUR253200
• Device Lot Number: 11647
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Weight: 84