MAUDE Adverse Event Report: COVIDIEN DEVON LITE GLOVE; COVER, BARRIER, PROTECTIVE

Catalog Number 31140257

Device Problem Split (2537)

Patient Problem No Information (3190)

Event Date 03/24/2015

Event Type  malfunction  

Event Description

The light handle cover split during the procedure several times.

• Brand Name: DEVON LITE GLOVE
• Type of Device: COVER, BARRIER, PROTECTIVE
• Manufacturer (Section D): COVIDIEN; 15 hampshire st; mansfield MA 02048
• MDR Report Key: 5010326
• MDR Text Key: 23259633
• Report Number: 5010326
• Device Sequence Number: 1
• Product Code: MMP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Report Date: 08/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 31140257
• Device Lot Number: 5019101464X
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/05/2015
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 08/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: OVER HEAD LIGHT