MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-05-15 for QUALI-QUICK TESTER manufactured by Medical Products, Inc..
[21963368]
The broth, which showed growth, was turbid. A small hairline crack was noted near the bottom of the vial although there was only slightly less volume in the vial. Had the turbidity not been noticed, the vial could have been used to check the sterility of a prepared product and growth could have been reported erroneously.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4002216 |
| MDR Report Key | 168711 |
| Date Received | 1998-05-15 |
| Date of Report | 1998-05-13 |
| Date Added to Maude | 1998-05-27 |
| 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 |
| 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 | QUALI-QUICK TESTER |
| Generic Name | STERILITY TESTER |
| Product Code | LRT |
| Date Received | 1998-05-15 |
| Model Number | NA |
| Catalog Number | NI |
| Lot Number | 7E107 |
| ID Number | PRODUCT NUMBER 73500 |
| Device Expiration Date | 1998-06-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 164118 |
| Manufacturer | MEDICAL PRODUCTS, INC. |
| Manufacturer Address | 1300 CHASE AVE. ELK GROVE VILLAGE IL 60007 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1998-05-15 |