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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CELL MARQUE CORPORATION C4D (SP91) RABBIT MONOCLONAL PRIMARY ANTIBODY

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CELL MARQUE CORPORATION C4D (SP91) RABBIT MONOCLONAL PRIMARY ANTIBODY Back to Search Results
Model Number PA0792
Device Problem Insufficient Information (3190)
Patient Problems Headache (1880); Hypersensitivity/Allergic reaction (1907); Pain (1994)
Event Date 02/19/2018
Event Type  Injury  
Event Description
On (b)(6) 2018, a call was received from (b)(6). She called to report that seven patients (6 females and 1 male) and employees of the hospital, came in to have an annual tb screening. All seven patients were injected with c4d (sp91) rabbit polyclonal antibody, predilute in a leica bond dispenser. The nurse practitioner assumed she was injecting tuberculin purified protein derivative also know as tubersol used in the testing for tb. Post injection six of the patients experienced the following physiological symptoms: - five of the seven patients experience headaches. - two patients had an allergic reaction. - one of the two patients experienced a delayed headache and developed a rash. The person with the delayed reaction had a severe headache with joint pain at the injection site. The patient was given a steroid and a antihistamine as well as a ct scan. The error was discovered within 2 hours of injection. At the treating physician's request and advice of the eh&s officer, the safety data sheet (sds) documents for the antibody, sodium azide and bovine serum were provided.
 
Manufacturer Narrative
This is a final report that no additional information or medical issues have been reported to cell marque corporation for this adverse event.
 
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Brand NameC4D (SP91)
Type of DeviceRABBIT MONOCLONAL PRIMARY ANTIBODY
Manufacturer (Section D)
CELL MARQUE CORPORATION
6600 sierra college blvd.
rocklin CA 95677
Manufacturer (Section G)
CELL MARQUE CORPORATION
frieda.casey@milliporesigma.c
rocklin 95677
Manufacturer Contact
frieda casey
6600 sierra college blvd
rocklin 95677
9167468977
MDR Report Key7974875
MDR Text Key124083511
Report Number1649339-2018-00004
Device Sequence Number1
Product Code NJT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Remedial Action Patient Monitoring
Type of Report Initial,Followup
Report Date 04/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/17/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/14/2020
Device Model NumberPA0792
Device Catalogue NumberPA0792
Device Lot Number52743
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA? No
Event Location Hospital
Date Manufacturer Received02/19/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/09/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 10/17/2018 Patient Sequence Number: 1
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