MAUDE Adverse Event Report: SHIJIAZHUANG EVERSHARP PLASTIC PRODUCTS CO., LTD. VINYL TOUCH; EXAMINATION GLOVE

Catalog Number 101094

Device Problem Contamination (1120)

Patient Problem Fungal Infection (2419)

Event Date 10/27/2016

Event Type  Injury  

Event Description

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.

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: VINYL TOUCH
• Type of Device: EXAMINATION GLOVE
• Manufacturer (Section D): SHIJIAZHUANG EVERSHARP PLASTIC PRODUCTS CO., LTD.; no 312 east long quan rd; luquan, hebei province 05000 0; CH 050000
• MDR Report Key: 6142187
• MDR Text Key: 61344419
• Report Number: 1019632-2016-00013
• Device Sequence Number: 1
• Product Code: LYZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 10/12/2016,02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 101094
• Device Lot Number: 15119726DF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/12/2016
• Distributor Facility Aware Date: 10/26/2016
• Device Age: 1 YR
• Event Location: Home
• Date Report to Manufacturer: 10/26/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/02/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/08/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR