Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
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
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 Rash (2033)
Event Date 06/07/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).
 
Event Description
It was reported by the health professional that two patients experienced rashes using chloraprep in the last month." hi there this is [omitted].I have had a surgeon inquire about if there has been any increase in rashes trending from the orange chloraprep."yes we did and we've been pulling those lots from our cardiovascular packs were we found those to be.And of course checking with any others.This specific surgeon, she has had two patients with rashes in the last month from the orange, so she wanted me to inquire if there was anything more going on.".
 
Manufacturer Narrative
No additional information was provided by midmichigan medical center.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.H3 other text : see narrative below.
 
Event Description
It was reported by the health professional that two patients experienced rashes using chloraprep in the last month." hi there this is [omitted].I have had a surgeon inquire about if there has been any increase in rashes trending from the orange chloraprep."yes we did and we've been pulling those lots from our cardiovascular packs were we found those to be.And of course checking with any others.This specific surgeon, she has had two patients with rashes in the last month from the orange, so she wanted me to inquire if there was anything more going on.".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
MDR Report Key11855666
MDR Text Key251897049
Report Number3004932373-2021-00247
Device Sequence Number1
Product Code KXG
Combination Product (y/n)Y
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup
Report Date 06/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Date Manufacturer Received06/07/2021
Patient Sequence Number1
Patient Outcome(s) Other;
-
-