MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-20 for ESTEEM STRETCHY NITRILE GLOVES 4816LSOR 8856NMBD manufactured by Unk.
[70737998]
Exam gloves were found to have pinpoint holes and tears when healthcare professional applied to hands. Also reports of the gloves splitting from cuff to fingertips when placed on hands. This issue involves five different lot numbers. Lot #4b16l504, pn# 8856nmbd esteem stretchy nitrile powder-free exam gloves.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5068574 |
| MDR Report Key | 6427138 |
| Date Received | 2017-03-20 |
| Date of Report | 2017-03-20 |
| Date of Event | 2017-03-16 |
| Date Added to Maude | 2017-03-23 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 3 |
| Brand Name | ESTEEM STRETCHY NITRILE GLOVES |
| Generic Name | ESTEEM STRETCHY NITRILE GLOVES |
| Product Code | LZA |
| Date Received | 2017-03-20 |
| Model Number | 4816LSOR |
| Catalog Number | 8856NMBD |
| Lot Number | 4B16L504 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-20 |