BROACH CORAIL AMT 12 L20412

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 2020-03-17 for BROACH CORAIL AMT 12 L20412 manufactured by Depuy France Sas - 3003895575.

MAUDE Entry Details

• Report Number: 1818910-2020-08342
• MDR Report Key: 9844559
• Report Source: COMPANY REPRESENTATIVE,HEALTH
• Date Received: 2020-03-17
• Date of Report: 2020-03-02
• Date of Event: 2020-03-02
• Date Mfgr Received: 2020-03-25
• Date Added to Maude: 2020-03-17
• 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: 700 ORTHOPAEDIC DR.
• Manufacturer City: WARSAW IN 465810988
• Manufacturer Country: US
• Manufacturer Postal: 465810988
• Manufacturer Phone: 6107428552
• Manufacturer G1: DEPUY ORTHOPAEDICS, INC. 1818910
• Manufacturer Street: 700 ORTHOPAEDIC DR. B.P. 256
• Manufacturer City: WARSAW IN 465810988
• Manufacturer Country: US
• Manufacturer Postal Code: 465810988
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: BROACH CORAIL AMT 12
• Generic Name: HIP INSTRUMENTS : BROACHES
• Product Code: HTQ
• Date Received: 2020-03-17
• Model Number: L20412
• Catalog Number: L20412
• Lot Number: UNKNOWN
• 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 FRANCE SAS - 3003895575
• Manufacturer Address: 7 ALLEE IRENE JOLIOT-CURIE B.P. 256 SAINT PRIEST CEDEX 69801 FR 69801

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-03-17