MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-02 for VINYL TOUCH 101094 manufactured by Shijiazhuang Eversharp Plastic Products Co., Ltd..
[61344419]
Customer bought vinyl gloves and used them to cook with in her kitchen for meats and food preparation. Customer indicated that they detected an odor on the gloves; characterizing the smell as moldy. Customer had not noticed the smell previously in work in the kitchen. Customer indicated later that the her finger nail split and shortly after contracted a fungal infection. She went to dermatologist and is now using ciclopirox until the nail can grow out the infection. Customer requested refund. On 12/2/2016, product sample received from customer 11/21/2016. The gloves had a plastic odor characteristic of vinyl gloves. No mold detected and product is within specification. No other action as of this date.
Patient Sequence No: 1, Text Type: D, B5
[66897083]
The manufacture date for these gloves was november 7-13, 2015. Device batch record indicates no deviations in the manufacture of these gloves from component/raw material receipt, processing, in process testing, and final release. There were no changes to suppliers or specification of raw materials used in the manufacture of the gloves. Retain samples from the same lot showed no discoloration or abnormal odor. Returned glove sample from customer showed no discoloration but the consumer sample smelled of soap/disinfectant which was not observed in manufactured product. No root cause could be identified and no further action on this complaint will occur.
Patient Sequence No: 1, Text Type: N, H10
[66897084]
Customer bought vinyl gloves and used them to cook with in her kitchen for meats and food preparation. Customer indicated that they detected an odor on the gloves; characterizing the smell as moldy. Customer had not noticed the smell previously in work in the kitchen. Customer indicated later that the her finger nail split and shortly after contracted a fungal infection. She went to dermatologist and is now using ciclopirox until the nail can grow out the infection. Customer requested refund. On 12/2/2016: product sample received from customer 11/21/2016. The gloves had a plastic odor characteristic of vinyl gloves. No mold detected and product is within specification. No other action as of this date.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1019632-2016-00013 |
| MDR Report Key | 6142187 |
| Date Received | 2016-12-02 |
| Date of Report | 2017-02-08 |
| Date of Event | 2016-10-27 |
| Date Facility Aware | 2016-10-26 |
| Report Date | 2016-10-12 |
| Date Reported to FDA | 2016-10-12 |
| Date Reported to Mfgr | 2016-10-26 |
| Date Added to Maude | 2016-12-02 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | 3 |
| Brand Name | VINYL TOUCH |
| Generic Name | EXAMINATION GLOVE |
| Product Code | LYZ |
| Date Received | 2016-12-02 |
| Returned To Mfg | 2016-11-21 |
| Catalog Number | 101094 |
| Lot Number | 15119726DF |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SHIJIAZHUANG EVERSHARP PLASTIC PRODUCTS CO., LTD. |
| Manufacturer Address | NO 312 EAST LONG QUAN RD LUQUAN, HEBEI PROVINCE 050000 CH 050000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-12-02 |