GALAFORM? 3D SCAFFOLD 100043-06 FR3D06

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 2019-07-08 for GALAFORM? 3D SCAFFOLD 100043-06 FR3D06 manufactured by Tepha, Inc.

MAUDE Entry Details

• Report Number: 3005670760-2018-00006
• MDR Report Key: 8767967
• Report Source: COMPANY REPRESENTATIVE,HEALTH
• Date Received: 2019-07-08
• Date of Report: 2019-07-02
• Date of Event: 2018-11-07
• Date Mfgr Received: 2018-12-28
• Device Manufacturer Date: 2018-06-18
• Date Added to Maude: 2019-07-08
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 0
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MRS BARBARA RINALDI
• Manufacturer Street: 99 HAYDEN AVE. SUITE 360
• Manufacturer City: LEXINGTON MA 02421
• Manufacturer Country: US
• Manufacturer Postal: 02421
• Manufacturer Phone: 7813251758
• Manufacturer G1: TEPHA, INC
• Manufacturer Street: 99 HAYDEN AVE
• Manufacturer City: LEXINGTON MA 02421
• Manufacturer Country: US
• Manufacturer Postal Code: 02421
• Single Use: 3
• Remedial Action: PM
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: GALAFORM? 3D SCAFFOLD
• Generic Name: SURGICAL SCAFFOLD, PRODUCT CODE: OXF
• Product Code: OXF
• Date Received: 2019-07-08
• Model Number: 100043-06
• Catalog Number: FR3D06
• Lot Number: 180250
• Device Expiration Date: 2019-06-08
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: TEPHA, INC
• Manufacturer Address: 99 HAYDEN AVE LEXINGTON MA 02421 US 02421

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2019-07-08