MAUDE Adverse Event Report: 3M HEALTH CARE 3M STERI-DRAPE U-DRAPE; DRAPE, SURGICAL

Model Number	1015
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Itching Sensation (1943); Rash (2033)
Date of Event	09/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient identifier, weight, ethnicity, race: not provided.No lot number was provided and no sample was available for analysis.
Event or Problem Description
Intense itchiness and a rash developed under the edge of a 3m steri-drape u-drape that was applied during a partial left hip revision surgery.Diphenhydramine was administered intravenously, and the symptoms resolved.The itchiness occurred on the chest below the breast area after the surgery ended and the rash was observed when the drape was removed.Chlorhexidine gluconate was used for skin preparation prior to the surgery; skin preparation products applied at the reaction site is unknown.

• Brand Name: 3M STERI-DRAPE U-DRAPE
• Common Device Name: DRAPE, SURGICAL
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• MDR Report Key: 12530413
• Report Number: 2110898-2021-00056
• Device Sequence Number: 17065606
• Product Code: PUI
• UDI-Device Identifier: 30707387018789
• UDI-Public: 30707387018789
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/24/2021

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
• Operator of Device: Health Professional
• Device Model Number: 1015
• Device Catalogue Number: 1015
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2021
• Initial Report FDA Received Date: 09/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR