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U.S. Department of Health and Human Services

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

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CAREFUSION 213, LLC 0113 CHLORAPREP UNKNOWN; 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL Back to Search Results
Catalog Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hypersensitivity/Allergic reaction (1907)
Event Date 05/21/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).No additional information was provided by the mhra.Primevigilance did reach out to obtain more information with no success.Should additional information be available in the future, the complaint will be re-opened and investigated.All complaints are reviewed during monthly quality/safety meetings.In addition, complaints are trended at monthly quality data analyst meetings and quarterly plant management review meetings.
 
Event Description
It was reported by the regulatory agency that the patient developed a rash, redness, spots, irritation, and itchiness when using chlorhexidine.Allergic to ametop.Has a rare neuro development genetic condition 14q duplication including foxg1 duplication.She's nearly (b)(6) and her ability is of a year old.Rash like sunburnt then blotchy then dark purple spots.Redness rash then spots, irritation, itchy seek advice details: was using piriton and e45 cream, it helped the redness but not the spots.
 
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Brand Name
CHLORAPREP UNKNOWN
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 Key11917970
MDR Text Key253722191
Report Number3004932373-2021-00267
Device Sequence Number1
Product Code KXF
Combination Product (y/n)Y
Reporter Country CodeUK
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Reporter Occupation Other Health Care Professional
Remedial Action Patient Monitoring
Type of Report Initial
Report Date 05/24/2021
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
Device Operator Other
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/21/2021
Initial Date FDA Received06/01/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age5 YR
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