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.
[124083123]
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. Relevant.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1649339-2018-00006 |
| MDR Report Key | 7974874 |
| Date Received | 2018-10-17 |
| Date of Report | 2018-04-13 |
| Date of Event | 2018-02-19 |
| Date Mfgr Received | 2018-02-19 |
| Device Manufacturer Date | 2017-10-09 |
| Date Added to Maude | 2018-10-17 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. FRIEDA CASEY |
| Manufacturer Street | 6600 SIERRA COLLEGE BLVD. |
| Manufacturer City | ROCKLIN 95677 |
| Manufacturer Country | US |
| Manufacturer Postal | 95677 |
| Manufacturer Phone | 9167468977 |
| Manufacturer G1 | CELL MARQUE CORPORATION |
| Manufacturer Street | 6600 SIERRA COLLEGE BLVD. |
| Manufacturer City | ROCKLIN 95677 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95677 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | C4D (SP91) |
| Generic Name | RABBIT MONOCLONAL PRIMARY ANTIBODY |
| Product Code | NJT |
| Date Received | 2018-10-17 |
| Model Number | PA0792 |
| Catalog Number | PA0792 |
| Lot Number | 52743 |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CELL MARQUE CORPORATION |
| Manufacturer Address | 6600 SIERRA COLLEGE BLVD. ROCKLIN CA 95677 US 95677 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-10-17 |