3611 LITE GLOVE 31140208

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-04 for 3611 LITE GLOVE 31140208 manufactured by Covidien.

Event Text Entries

[56801019] An investigation is currently under way; upon completion the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10

[56801020] It was reported to covidien on (b)(6) 2016 that a customer had an issue with a lite glove. The customer states that the product is too tight and split when trying to place it on the lamp handle.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 9612030-2016-00491
• MDR Report Key: 5996325
• Date Received: 2016-10-04
• Date of Report: 2016-09-19
• Date Mfgr Received: 2016-09-19
• Date Added to Maude: 2016-10-04
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: EDWARD ALMEIDA
• Manufacturer Street: 15 HAMPSHIRE STREET
• Manufacturer City: MANSFIELD MA 02048
• Manufacturer Country: US
• Manufacturer Postal: 02048
• Manufacturer Phone: 5084524151
• Manufacturer G1: COVIDIEN
• Manufacturer Street: CALLE 9 SUR NO. 125 CUIDAD INDUSTRIAL
• Manufacturer City: TIJUANA
• Manufacturer Country: MX
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: 3611 LITE GLOVE
• Generic Name: LITE GLOVE
• Product Code: LYU
• Date Received: 2016-10-04
• Model Number: 31140208
• Catalog Number: 31140208
• Lot Number: 6162100464
• Device Availability: Y
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: COVIDIEN
• Manufacturer Address: CALLE 9 SUR NO. 125 CUIDAD INDUSTRIAL TIJUANA MX

Patients

Patient Number	Treatment	Outcome	Date
1	0		2016-10-04