MAUDE Adverse Event Report: COVIDIEN NS-3600-B LITE GLOVE 1000/CASE

Model Number 571711

Device Problem Torn Material (3024)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2016 that a customer had an issue with a lite glove.The customer reports that the lite glove tore.

• Brand Name: NS-3600-B LITE GLOVE 1000/CASE
• Type of Device: LITE GLOVE
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad; industrial; tijuana ; MX
• Manufacturer (Section G): COVIDIEN; calle 9 sur no. 125 cuidad; industrial; tijuana ; MX
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6124565
• MDR Text Key: 61088313
• Report Number: 9612030-2016-00711
• Device Sequence Number: 1
• Product Code: LYU
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/26/2016

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
• Device Operator: Other
• Device Model Number: 571711
• Device Catalogue Number: 571711
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/26/2016
• Initial Date FDA Received: 11/23/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1