MAUDE Adverse Event Report: COVIDIEN 3612 LITE GLOVE

Model Number	31140257
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/30/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently under way; upon completion the results will be forwarded.
Event or Problem Description
It was reported to covidien on (b)(6) 2016 that a customer had an issue with a lite glove.The customer reports the light gloves are tearing up the middle upon application to the devon light handles.The material seems to differ in thickness and density depending on what section.The section that slips onto the handles is where the damage is occurring and appears to be more transparent/thinner than the cuff and tip.

• Brand Name: 3612 LITE GLOVE
• Common Device Name: LITE GLOVE
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad; industrial; tijuana ; MX
• MDR Report Key: 6174784
• Report Number: 9612030-2016-00817
• Device Sequence Number: 18945564
• Product Code: FMC
• UDI-Device Identifier: 30884527011739
• UDI-Public: (01)30884527011739(17)190601(10)6158100
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/05/2016

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
• Operator of Device: Other
• Device Model Number: 31140257
• Device Catalogue Number: 31140257
• Device Lot Number: 6158100364
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2016
• Initial Report FDA Received Date: 12/15/2016
• Patient Sequence Number: 1