COOK CERVICAL RIPENING BALLOON W/STYLET G19891 J-CRBS-184000

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 2019-10-04 for COOK CERVICAL RIPENING BALLOON W/STYLET G19891 J-CRBS-184000 manufactured by Cook Inc.

MAUDE Entry Details

• Report Number: 1820334-2019-02540
• MDR Report Key: 9158254
• Report Source: COMPANY REPRESENTATIVE,FOREIG
• Date Received: 2019-10-04
• Date of Report: 2019-11-07
• Date of Event: 2019-09-23
• Date Mfgr Received: 2019-11-13
• Device Manufacturer Date: 2019-02-12
• Date Added to Maude: 2019-10-04
• 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
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MR. LARRY POOL
• Manufacturer Street: 750 DANIELS WAY
• Manufacturer City: BLOOMINGTON IN 47404
• Manufacturer Country: US
• Manufacturer Postal: 47404
• Manufacturer Phone: 8123392235
• Manufacturer G1: COOK INC
• Manufacturer Street: 750 DANIELS WAY
• Manufacturer City: BLOOMINGTON IN 47404
• Manufacturer Country: US
• Manufacturer Postal Code: 47404
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: COOK CERVICAL RIPENING BALLOON W/STYLET
• Generic Name: PFJ, DILATOR, CERVICAL, HYGROSCOPIC-IAMINARIA
• Product Code: PFJ
• Date Received: 2019-10-04
• Model Number: G19891
• Catalog Number: J-CRBS-184000
• Lot Number: 9514248
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: COOK INC
• Manufacturer Address: 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2019-10-04