MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-06-03 for CLEAR VU VIAL 1-CLIC Z-40 1-CLIC CL-58 1 CLIC CLOSURE manufactured by Owens-brockway Plastic Products/maumee Plant.
[132308]
Prescription vials with child resistant closure that failed. Closure mechanism fails and makes it easy for children to open vial. Other size vials were also tested and found to fail.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1016467 |
| MDR Report Key | 226318 |
| Date Received | 1999-06-03 |
| Date of Report | 1999-06-03 |
| Date of Event | 1999-06-02 |
| Date Added to Maude | 1999-06-11 |
| 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 | CLEAR VU VIAL 1-CLIC |
| Generic Name | PRESCRIPTION VIALS |
| Product Code | NXB |
| Date Received | 1999-06-03 |
| Model Number | Z-40 1-CLIC |
| Catalog Number | CL-58 1 CLIC CLOSURE |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 219469 |
| Manufacturer | OWENS-BROCKWAY PLASTIC PRODUCTS/MAUMEE PLANT |
| Manufacturer Address | 360 TOMAHAWK DR MAUMEE OH 43537 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1999-06-03 |