MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-05-11 for KERR 12 DRAM PRESCRIPTION VIAL * 15512 manufactured by Kerr Prescription Packaging.
[140702]
One of the rptr's pts returned a prescription dispensed in a 12 dram kerr prescription vial. The pt described the vial as having a red stain. The rptr affirms the brown plastic as being discolored, having streaks of red. The coloring is not uniform. The pt also thought his tablets smelled differently in that vial, as well.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1016317 |
| MDR Report Key | 223208 |
| Date Received | 1999-05-11 |
| Date of Report | 1999-05-11 |
| Date Added to Maude | 1999-05-18 |
| 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 | KERR 12 DRAM PRESCRIPTION VIAL |
| Generic Name | PACKAGED WITH CHILD-RESISTANT CAPS |
| Product Code | NXB |
| Date Received | 1999-05-11 |
| Model Number | * |
| Catalog Number | 15512 |
| Lot Number | 00032747 |
| ID Number | * |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 216469 |
| Manufacturer | KERR PRESCRIPTION PACKAGING |
| Manufacturer Address | 1005 LOWER BROWNSVILLE RD. JACKSON TN 38301 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1999-05-11 |