CE82 DELIVERY SYSTEM 2000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-10 for CE82 DELIVERY SYSTEM 2000 manufactured by Coopersurgical, Inc..

Event Text Entries

[144968386] Coopersurgical, inc. Is investigating the condition reported. (b)(4).
Patient Sequence No: 1, Text Type: N, H10

[144968387] Customer stated: temperature gauge is not working and when depressing pedal it sounds like a lot of air is escaping. (b)(4).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1216677-2019-00076
• MDR Report Key: 8601134
• Date Received: 2019-05-10
• Date of Report: 2019-05-10
• Date of Event: 2019-02-26
• Date Mfgr Received: 2019-05-02
• Date Added to Maude: 2019-05-10
• 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: MR. PETER NIZIOLEK
• Manufacturer Street: 50 CORPORATE DRIVE
• Manufacturer City: TRUMBULL CT 06611
• Manufacturer Country: US
• Manufacturer Postal: 06611
• Manufacturer Phone: 2036015200
• Manufacturer G1: COOPERSURGICAL, INC.
• Manufacturer Street: 75 CORPORATE DRIVE
• Manufacturer City: TRUMBULL CT 06611
• Manufacturer Country: US
• Manufacturer Postal Code: 06611
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: CE82 DELIVERY SYSTEM
• Generic Name: CE82 DELIVERY SYSTEM
• Product Code: HQA
• Date Received: 2019-05-10
• Model Number: 2000
• Catalog Number: 2000
• Lot Number: 8846
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: COOPERSURGICAL, INC.
• Manufacturer Address: 95 CORPORATE DRIVE TRUMBULL CT 06611 US 06611

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2019-05-10