C4D (SP91) PA0792

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-17 for C4D (SP91) PA0792 manufactured by Cell Marque Corporation.

Event Text Entries

[124082853] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1649339-2018-00002
MDR Report Key7974902
Date Received2018-10-17
Date of Report2018-04-13
Date of Event2018-02-19
Date Mfgr Received2018-02-19
Device Manufacturer Date2017-10-09
Date Added to Maude2018-10-17
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Manufacturer ContactMS. FRIEDA CASEY
Manufacturer Street6600 SIERRA COLLEGE BLVD.
Manufacturer CityROCKLIN 95677
Manufacturer CountryUS
Manufacturer Postal95677
Manufacturer Phone9167468977
Manufacturer G1CELL MARQUE CORPORATION
Manufacturer Street6600 SIERRA COLLEGE BLVD.
Manufacturer CityROCKLIN 95677
Manufacturer CountryUS
Manufacturer Postal Code95677
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameC4D (SP91)
Generic NameRABBIT MONOCLONAL PRIMARY ANTIBODY
Product CodeNJT
Date Received2018-10-17
Model NumberPA0792
Catalog NumberPA0792
Lot Number52743
Device Availability*
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerCELL MARQUE CORPORATION
Manufacturer Address6600 SIERRA COLLEGE BLVD. ROCKLIN CA 95677 US 95677


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2018-10-17

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