MAUDE Adverse Event Report: CAREFUSION, INC UNKNOWN CHLORAPREP; NOT SPECIFIED

Catalog Number UNKNOWN

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

Patient Problem Reaction (2414)

Event Date 07/31/2020

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

Event description per attached email states: my patient recently reported an allergic rash after giving blood.She was not certain which chloraprep product they use.She has a known allergies to macrobid and shellfish.What is the most likely ingredient to which she is allergic.".

• Brand Name: UNKNOWN CHLORAPREP
• Type of Device: NOT SPECIFIED
• Manufacturer (Section D): CAREFUSION, INC; 75 n. fairview drive; vernon hills IL 60061
• 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: 10404819
• MDR Text Key: 210178586
• Report Number: 3004932373-2020-00001
• Device Sequence Number: 1
• Product Code: KXF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/13/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/31/2020
• Initial Date FDA Received: 08/13/2020
• 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