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 08/03/2020

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

Event description ; verbatim: anaphylactic shock; meddra llt anaphylactic shock, meddra pt anaphylactic shock, serious.Material no.: unknown batch no.: unknown.

• 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: 10423717
• MDR Text Key: 205333725
• Report Number: 3004932373-2020-00002
• Device Sequence Number: 1
• Product Code: KXF
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/03/2020
• Initial Date FDA Received: 08/18/2020
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR