STAPLE, 24 MM 172802024

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 2020-03-10 for STAPLE, 24 MM 172802024 manufactured by Medos International Sàrl Ch.

MAUDE Entry Details

• Report Number: 1526439-2020-00680
• MDR Report Key: 9812934
• Report Source: COMPANY REPRESENTATIVE,HEALTH
• Date Received: 2020-03-10
• Date of Report: 2020-02-12
• Date of Event: 2020-02-11
• Date Mfgr Received: 2020-03-19
• Date Added to Maude: 2020-03-10
• 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: 325 PARAMOUNT DRIVE
• Manufacturer City: RAYNHAM MA 02767
• Manufacturer Country: US
• Manufacturer Postal: 02767
• Manufacturer Phone: 6103142063
• Manufacturer G1: BRIDGEWATER DISTRIBUTION
• Manufacturer Street: 50 SCOTLAND BOULEVARD
• Manufacturer City: BRIDGEWATER MA 02324
• Manufacturer Country: US
• Manufacturer Postal Code: 02324
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: STAPLE, 24 MM
• Generic Name: APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY
• Product Code: KWQ
• Date Received: 2020-03-10
• Returned To Mfg: 2020-03-05
• Model Number: 172802024
• Catalog Number: 172802024
• Lot Number: WA21807
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: DA
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MEDOS INTERNATIONAL SàRL CH
• Manufacturer Address: CHEMIN-BLANC 38 LE LOCLE 02400 SZ 02400

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2020-03-10