MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-12-19 for QC TESTER * QC0100 manufactured by Mcgaw, Inc..
[39307]
Five of the filter/culture chambers leaked when culture media was put in the chamber. In all cases the leak occurred at a cemented seal used to join the dome of the chamber to the base.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1010438 |
| MDR Report Key | 57223 |
| Date Received | 1996-12-19 |
| Date Added to Maude | 1996-12-23 |
| 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 |
| Reporter Occupation | PHARMACIST |
| 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 | QC TESTER |
| Generic Name | CULTURE MEDIA CHAMBER |
| Product Code | JTR |
| Date Received | 1996-12-19 |
| Model Number | * |
| Catalog Number | QC0100 |
| Lot Number | E076 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 57722 |
| Manufacturer | MCGAW, INC. |
| Manufacturer Address | 2525 MCGAW AVE PO BOX 19791 IRVINE CA 92714 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-12-19 |