PHASIX ST MESH 1201015

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional report with the FDA on 2019-07-10 for PHASIX ST MESH 1201015 manufactured by Davol Inc., Sub. C.r. Bard, Inc..

MAUDE Entry Details

• Report Number: 1213643-2019-05908
• MDR Report Key: 8776768
• Report Source: CONSUMER,HEALTH PROFESSIONAL
• Date Received: 2019-07-10
• Date of Report: 2019-08-06
• Date of Event: 2018-10-30
• Date Mfgr Received: 2019-08-06
• Device Manufacturer Date: 2018-06-13
• Date Added to Maude: 2019-07-10
• 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
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: LAURA SUNDBERG
• Manufacturer Street: 100 CROSSINGS BLVD.
• Manufacturer City: WARWICK RI 02886
• Manufacturer Country: US
• Manufacturer Postal: 02886
• Manufacturer Phone: 4018258462
• Manufacturer G1: BARD SHANNON LIMITED -3005636544
• Manufacturer Street: SAN GERONIMO INDUSTRIAL PARK LOT #1, ROAD #3, KM 79.7
• Manufacturer City: HUMACAO PR 00791
• Manufacturer Country: US
• Manufacturer Postal Code: 00791
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: PHASIX ST MESH
• Generic Name: SURGICAL MESH
• Product Code: OWT
• Date Received: 2019-07-10
• Model Number: NA
• Catalog Number: 1201015
• Lot Number: HUCQ1645
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: DAVOL INC., SUB. C.R. BARD, INC.
• Manufacturer Address: 100 CROSSINGS BLVD. WARWICK RI 02886 US 02886

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2019-07-10