DEVON 31160495

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-06-20 for DEVON 31160495 manufactured by Covidien.

Event Text Entries

[78040059] Submit date: 6/20/17. An investigation is currently under way; upon completion the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10

[78040060] The customer states the markers are exploding in the pack.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 9612030-2017-05111
• MDR Report Key: 6654852
• Report Source: DISTRIBUTOR
• Date Received: 2017-06-20
• Date of Report: 2018-01-08
• Date of Event: 2017-05-10
• Date Mfgr Received: 2017-05-26
• Date Added to Maude: 2017-06-20
• 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
• Manufacturer City: TIJUANA,NA 92173
• Manufacturer Country: MX
• Manufacturer Postal Code: 92173
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: DEVON
• Generic Name: MARKER, SKIN
• Product Code: FZZ
• Date Received: 2017-06-20
• Model Number: 31160495
• Catalog Number: 31160495
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: COVIDIEN
• Manufacturer Address: CALLE 9 SUR NO. 125 CUIDAD TIJUANA,NA 92173 MX 92173

Patients

Patient Number	Treatment	Outcome	Date
1	0		2017-06-20