MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-08-17 for VERSA VIAL, 2 OZ. CONTAINER 10253 * manufactured by Capital Vial, Inc..
[503695]
Upon opening this container, a strong "chemical-like" odor was detected. After leaving the cap off for several minutes, the odor became less noticeable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1040104 |
| MDR Report Key | 755188 |
| Date Received | 2006-08-17 |
| Date of Report | 2006-08-17 |
| Date Added to Maude | 2006-08-30 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VERSA VIAL, 2 OZ. CONTAINER |
| Generic Name | BREASTMILK COLLECTION CONTAINER |
| Product Code | NNI |
| Date Received | 2006-08-17 |
| Model Number | 10253 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 743007 |
| Manufacturer | CAPITAL VIAL, INC. |
| Manufacturer Address | 2039 MCMILLAN ST. AUBURN AL 36832 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-08-17 |