MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-03-16 for STREPTEX LATEX GRP, A ZL51 manufactured by Murex Corp..
[17111125]
Quality control for product showed agglutination with strep a (positive control), strep b (negative control), and sterile distilled water. The product was autoagglutinating.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1001093 |
| MDR Report Key | 12048 |
| Date Received | 1994-03-16 |
| Date of Report | 1994-03-10 |
| Date of Event | 1994-03-09 |
| Date Added to Maude | 1994-03-17 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STREPTEX LATEX GRP, A |
| Product Code | GTY |
| Date Received | 1994-03-16 |
| Catalog Number | ZL51 |
| Lot Number | K182710 |
| Device Expiration Date | 1994-12-28 |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 12048 |
| Manufacturer | MUREX CORP. |
| Manufacturer Address | NORCROSS GA 300711542 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-03-16 |