MAUDE Adverse Event Report: CAREFUSION 213, LLC 0113 UNKNOWN CHLORAPREP; 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 06/02/2021

Event Type  Injury  

Manufacturer Narrative

Pr (b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).

Event Description

Material no.: unknown ; batch no.: unknown.It was reported by the health professional that patients developed contact dermatitis after use of chloraprep.Per email: i have an orthopedic surgeon from our facility with complaints of severe contact dermatitis post-op following use of the 26ml orange tinted chloraprep stick.Approximately 6 patients in a two week period in april developed the contact dermatitis in the same extremity in the same area as the chloraprep was applied.A general surgeon also confirmed he had one case of contact dermatitis on an abdomen in the exact area we had prepped in the same time period.

• Brand Name: UNKNOWN CHLORAPREP
• Type of Device: 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL
• Manufacturer (Section D): CAREFUSION 213, LLC 0113; 1550 northwestern dr; el paso TX 79912
• Manufacturer (Section G): CAREFUSION, INC; 75 n. fairview drive; vernon hills IL 60061
• Manufacturer Contact: anna wehrheim ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 11998348
• MDR Text Key: 256166963
• Report Number: 3004932373-2021-00291
• Device Sequence Number: 1
• Product Code: KXF
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date: 06/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 06/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other