TRUMATCH CT CUT GUIDE KIT R 420916

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-01-17 for TRUMATCH CT CUT GUIDE KIT R 420916 manufactured by Depuy Ireland - 9616671.

MAUDE Entry Details

• Report Number: 1818910-2020-02213
• MDR Report Key: 9603816
• Report Source: COMPANY REPRESENTATIVE,HEALTH
• Date Received: 2020-01-17
• Date of Report: 2020-01-06
• Date of Event: 2020-01-06
• Date Mfgr Received: 2020-01-28
• Device Manufacturer Date: 2019-12-09
• Date Added to Maude: 2020-01-17
• 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
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MS. KARA DITTY-BOVARD
• Manufacturer Street: 1210 WARD AVENUE
• Manufacturer City: WEST CHESTER IN 193800988
• Manufacturer Country: US
• Manufacturer Postal: 193800988
• Manufacturer Phone: 6107428552
• Manufacturer G1: DEPUY RAYNHAM, A DIV. OF DEPUY ORTHO 1219655
• Manufacturer Street: ST. ANTHONY ROAD
• Manufacturer City: LEEDS MA 02767
• Manufacturer Country: US
• Manufacturer Postal Code: 02767
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: TRUMATCH CT CUT GUIDE KIT R
• Generic Name: TRUMATCH INSTRUMENTS : RESECTION BLOCKS/DEVICES
• Product Code: FSM
• Date Received: 2020-01-17
• Model Number: 420916
• Catalog Number: 420916
• Lot Number: 20996
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: DEPUY IRELAND - 9616671
• Manufacturer Address: LOUGHBEG RINGASKIDDY CO. CORK EI

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-01-17