MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-09-18 for GAMMA * manufactured by Gamma.
[169293]
Gamma fetal bleed screening test for the detection of d-positive red cells in d-negative mothers after delivery. Positive control did not test positive. Replacement reagent shipped.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1019993 |
| MDR Report Key | 297548 |
| Date Received | 2000-09-18 |
| Date of Report | 2000-09-14 |
| Date of Event | 2000-09-08 |
| Date Added to Maude | 2000-09-27 |
| 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 | GAMMA |
| Generic Name | * |
| Product Code | LIM |
| Date Received | 2000-09-18 |
| Returned To Mfg | 2000-09-11 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 0829 |
| ID Number | * |
| Device Expiration Date | 2000-10-04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 288006 |
| Manufacturer | GAMMA |
| Manufacturer Address | 3700 MANGUM RD HOUSTON TX 77092 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2000-09-18 |