HEDGEHOG SBB-382-50 60252

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 2019-09-09 for HEDGEHOG SBB-382-50 60252 manufactured by Boston Scientific Corporation.

MAUDE Entry Details

• Report Number: 3005099803-2019-04398
• MDR Report Key: 8974194
• Report Source: COMPANY REPRESENTATIVE,FOREIG
• Date Received: 2019-09-09
• Date of Report: 2019-09-09
• Date of Event: 2019-08-09
• Date Mfgr Received: 2019-08-12
• Device Manufacturer Date: 2018-06-15
• Date Added to Maude: 2019-09-09
• 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: CAROLE MORLEY
• Manufacturer Street: 300 BOSTON SCIENTIFIC WAY
• Manufacturer City: MARLBOROUGH MA 01752
• Manufacturer Country: US
• Manufacturer Postal: 01752
• Manufacturer Phone: 5086834015
• Manufacturer G1: SUZHOU TEMEIRUI MEDICAL PRODUCTS CO., LTD
• Manufacturer Street: NO 699 PINAN ROAD PUZHAUNG LINHU TOWN,
• Manufacturer City: WUZHONG DISTRICT, SUZHOU 21505
• Manufacturer Country: CH
• Manufacturer Postal Code: 21505
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: HEDGEHOG
• Generic Name: ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE
• Product Code: MNL
• Date Received: 2019-09-09
• Model Number: SBB-382-50
• Catalog Number: 60252
• Lot Number: 0000180531
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BOSTON SCIENTIFIC CORPORATION
• Manufacturer Address: 300 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-09-09