MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-25 for POWDERED GLOVES manufactured by Unk.
[76283590]
The fda recently banned powdered gloves due to the powder being a danger to the user of the product. The same powder which has been banned is allowed in food service because they are not classified as medical device. Use is still a hazard regardless of intended use. Incident location: school. May we include your report, including any documents or photographs that you have attached to your report, but without your name and contact information, in cpsc's public database: yes. I certify that i have reviewed the report and that the information provided in this report is true and accurate to the best of my knowledge, information and belief: yes. Document number: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5070059 |
| MDR Report Key | 6597656 |
| Date Received | 2017-05-25 |
| Date of Report | 2017-05-11 |
| Date of Event | 2017-05-11 |
| Date Added to Maude | 2017-05-30 |
| 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 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | POWDERED GLOVES |
| Generic Name | POWDERED GO=OFES. |
| Product Code | LYY |
| Date Received | 2017-05-25 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-25 |