HYDROMARK BREAST BIOPSY SITE MARKER 4010-02-15-T3

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-10-10 for HYDROMARK BREAST BIOPSY SITE MARKER 4010-02-15-T3 manufactured by Devicor Medical Products, Inc.

MAUDE Entry Details

• Report Number: 3008492462-2019-00047
• MDR Report Key: 9177286
• Report Source: HEALTH PROFESSIONAL
• Date Received: 2019-10-10
• Date of Report: 2019-10-10
• Date of Event: 2019-09-17
• Date Mfgr Received: 2019-09-17
• Date Added to Maude: 2019-10-10
• 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: MRS. RHONDA KOPS
• Manufacturer Street: 300 E BUSINESS WAY FIFTH FLOOR
• Manufacturer City: CINCINNATI OH 45241
• Manufacturer Country: US
• Manufacturer Postal: 45241
• Manufacturer G1: DEVICOR MEDICAL PRODUCTS DE MEXICO
• Manufacturer Street: SOR JUANAINES DE LA CRUZ #20152 4-B
• Manufacturer City: PARQUE INDUSTRIAL, TIJUANA 22440
• Manufacturer Country: MX
• Manufacturer Postal Code: 22440
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: HYDROMARK BREAST BIOPSY SITE MARKER
• Generic Name: BIOPSY SITE IDENTIFIER
• Product Code: NEU
• Date Received: 2019-10-10
• Model Number: 4010-02-15-T3
• Catalog Number: 4010-02-15-T3
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: DEVICOR MEDICAL PRODUCTS, INC
• Manufacturer Address: 300 E. BUSINESS WAY FIFTH FLOOR CINCINNATI OH 45241 US 45241

Patients

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