ENDO CLINCH II 174317

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 2019-06-28 for ENDO CLINCH II 174317 manufactured by Us Surgical Puerto Rico.

MAUDE Entry Details

• Report Number: 2647580-2019-03402
• MDR Report Key: 8746692
• Report Source: COMPANY REPRESENTATIVE,HEALTH
• Date Received: 2019-06-28
• Date of Report: 2019-08-29
• Date of Event: 2019-06-03
• Date Mfgr Received: 2019-08-07
• Device Manufacturer Date: 2019-03-07
• Date Added to Maude: 2019-06-28
• 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: LISA HERNANDEZ
• Manufacturer Street: 60 MIDDLETOWN AVE.
• Manufacturer City: NORTH HAVEN CT 06473
• Manufacturer Country: US
• Manufacturer Postal: 06473
• Manufacturer Phone: 2034925563
• Manufacturer G1: US SURGICAL PUERTO RICO
• Manufacturer Street: 201 SABANETAS INDUSTRIAL PARK
• Manufacturer City: PONCE PR 007164401
• Manufacturer Country: US
• Manufacturer Postal Code: 007164401
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ENDO CLINCH II
• Generic Name: FORCEPS, OBSTETRICAL
• Product Code: HDA
• Date Received: 2019-06-28
• Returned To Mfg: 2019-06-19
• Model Number: 174317
• Catalog Number: 174317
• Lot Number: P9C1327Y
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: DA
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: US SURGICAL PUERTO RICO
• Manufacturer Address: 201 SABANETAS INDUSTRIAL PARK PONCE PR 007164401 US 007164401

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-06-28