1.25 THREADED GUIDE WIRE- SPADE POINT ON BOTH ENDS 150MM 292.62

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-01-28 for 1.25 THREADED GUIDE WIRE- SPADE POINT ON BOTH ENDS 150MM 292.62 manufactured by Oberdorf Synthes Produktions Gmbh.

MAUDE Entry Details

• Report Number: 8030965-2020-00687
• MDR Report Key: 9637871
• Report Source: COMPANY REPRESENTATIVE,FOREIG
• Date Received: 2020-01-28
• Date of Report: 2020-01-07
• Date of Event: 2020-01-07
• Date Mfgr Received: 2020-02-06
• Date Added to Maude: 2020-01-28
• 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: KARA DITTY-BOVARD
• Manufacturer Street: 1302 WRIGHTS LANE EAST
• Manufacturer City: WEST CHESTER PA 19380
• Manufacturer Country: US
• Manufacturer Postal: 19380
• Manufacturer Phone: 6103142063
• Manufacturer G1: ELMIRA
• Manufacturer Street: 35 AIRPORT ROAD
• Manufacturer City: HORSEHEADS NY 14845
• Manufacturer Country: US
• Manufacturer Postal Code: 14845
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: 1.25 THREADED GUIDE WIRE- SPADE POINT ON BOTH ENDS 150MM
• Generic Name: WIRE, SURGICAL
• Product Code: LRN
• Date Received: 2020-01-28
• Catalog Number: 292.62
• Lot Number: 5L76602
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: OBERDORF SYNTHES PRODUKTIONS GMBH
• Manufacturer Address: EIMATTSTRASSE 3 OBERDORF 4436 SZ 4436

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2020-01-28