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

Model Number	1010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Itching Sensation (1943); Rash (2033)
Date of Event	07/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient identifier & weight: information was not provided.Without a lot number, the expiration date and manufacture date could not be determined.No sample was received for analysis and no lot number was provided.A 2-year review of historical complaint data showed no trends.3m will continue to monitor.
Event or Problem Description
A physician reported that a patient developed suspected contact dermatitis, described as skin rash with redness, itchiness and blisters along the drape edges after application of a 3m¿ steri-drape¿ large towel drape 1010 during spinal surgery.The rash is located on the anterior neck/superior torso region, size reported as greater than 25x6cm at the largest linear region.Skin preparation included application of mastisol® liquid adhesive.The skin was reported as dry prior to application of the drape.The drape was in place 1-2 days before the symptoms began.Medical treatment consisted of intravenous, oral, and topical corticosteroids.Healing is in progress and the patient is reported as in stable condition.
Additional Manufacturer Narrative
Patient age was not provided; added , weight of (b)(6) kg.

• Brand Name: 3M STERI-DRAPE LARGE TOWEL DRAPE
• Common Device Name: DRAPE, SURGICAL
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; mn
• MDR Report Key: 10376373
• Report Number: 2110898-2020-00040
• Device Sequence Number: 2567209
• Product Code: PUI
• UDI-Device Identifier: 30707387057252
• UDI-Public: 30707387057252
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2020

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: 1010
• Device Catalogue Number: 1010
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2020
• Supplement Date Received by Manufacturer: 07/21/2020
• Initial Report FDA Received Date: 08/06/2020
• Supplement Report FDA Received Date: 08/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MASTISOL® LIQUID ADHESIVE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR
• Patient Weight: 85