MAUDE Adverse Event Report: 3M HEALTH CARE 3M IOBAN(TM) 2 ANTIMICROBIAL INCISE DRAPE

Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Reaction (2414)
Date of Event	08/05/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pt info: this information was not provided by the initial reporter.Mfg date: no catalog number was provided.No lot number or expiration date was provided.Can not determine manufacturing date without lot number.The product was not returned.The patient was noted to have an iodine allergy and also wears an iodine allergy bracelet.The instructions for use includes the following: "contraindication: do not use ioban 2 antimicrobial incise drape on patients with known sensitivity to iodine." the drape used in the reported event contains iodine.Failure to follow instructions most likely contributed to the event.End of report.
Event or Problem Description
A pharmacist reported through the fda voluntary event report system that a female patient, age unspecified, had skin grafting for a right chest wound abscess on (b)(6) 2015.The woman was receiving clindamycin for cellulitis.The woman was wearing an iodine allergy bracelet when a 3m ioban(tm) 2 drape (model not specified) was placed on the surgical site.The woman allegedly had acute onset of tongue swelling, drooling, dyspnea, profound hypotension, and acute depressed mental status.Her condition rapidly reversed when she was given subcutaneous epinephrine.The woman was transferred to intensive care for 24 hour monitoring.She was given diphenhydramine and recovered.

• Brand Name: 3M IOBAN(TM) 2 ANTIMICROBIAL INCISE DRAPE
• Common Device Name: INCISE DRAPE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• MDR Report Key: 5458288
• Report Number: 2110898-2016-00019
• Device Sequence Number: 496
• Product Code: KKX
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K801550
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 01/21/2016

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2016
• Initial Report FDA Received Date: 02/24/2016
• 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: Other