MAUDE Adverse Event Report: 3M HEALTH CARE 3M STERI-DRAPE LARGE TOWEL DRAPE 1010; DRAPE, SURGICAL

Model Number	1010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Anaphylactic Shock (1703); Erythema (1840); Itching Sensation (1943); Swelling (2091); Burning Sensation (2146)
Date of Event	06/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient 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 were observed.3m will continue to monitor.
Event or Problem Description
An anaphylactic reaction was reported that occurred six days after a cervical fusion surgery protected by a 3m¿ steri-drape¿ large towel drape 1010.A medical alert band was worn the day of surgery due to prior skin reactions with adhesives.The consumer went to the emergency room six days after surgery due to symptoms of facial itchiness with a burning sensation and facial and throat swelling.An intravenous infusion of diphenhydramine and a steroid was administered, and the symptoms resolved.The consumer was discharged from the emergency room the same day.Skin redness under the adhesive area of the 3m¿ steri-drape¿ large towel drape 1010 was also observed.

• Brand Name: 3M STERI-DRAPE LARGE TOWEL DRAPE 1010
• Common Device Name: DRAPE, SURGICAL
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul, mn
• MDR Report Key: 9899124
• Report Number: 2110898-2020-00018
• Device Sequence Number: 11460335
• 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: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/30/2020

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: 03/11/2020
• Initial Report FDA Received Date: 03/30/2020
• 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: Life Threatening; Required Intervention