MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-09-18 for ANSELL manufactured by Ansell.
[3741237]
Caller complained about a foul odor from the ansell vinyl-toch gloves. This product which is made in china emits a very strong and foul odor as soon as the box is opened. The caller is concerned that these gloves could be inflammable or they could be a health hazard. He stated that his wife uses the gloves for every day house chores and for bathing and feeding her daughter. The caller has called the mfr and left voice messages, but nobody has called back. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5031971 |
| MDR Report Key | 3365755 |
| Date Received | 2013-09-18 |
| Date of Report | 2013-09-18 |
| Date Added to Maude | 2013-09-25 |
| 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 | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANSELL |
| Generic Name | VINYL-TOUCH GLOVES |
| Product Code | LYY |
| Date Received | 2013-09-18 |
| Lot Number | 13054088DF |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANSELL |
| Manufacturer Address | DOTHAM AL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-09-18 |