MAUDE Adverse Event Report: COVIDIEN DEVON; LIGHT HANDLE COVER

Model Number 31140208

Device Problem Nonstandard Device (1420)

Patient Problem No Information (3190)

Event Type  Other  

Event Description

Recall of covidien, devon light glove.Product #31140208.

• Brand Name: DEVON
• Type of Device: LIGHT HANDLE COVER
• Manufacturer (Section D): COVIDIEN; mansfield MA 02048
• MDR Report Key: 6228253
• MDR Text Key: 64144953
• Report Number: MW5067065
• Device Sequence Number: 1
• Product Code: FSY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Model Number: 31140208
• Device Catalogue Number: 31140208
• Device Lot Number: 630XXXXXXXLOWER
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: DEVON LIGHT HANDLE COVER; GREEN COVER ; STERILE LIGHT HANDLE COVER