XENMATRIX AB 1153045

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other,stu report with the FDA on 2019-07-15 for XENMATRIX AB 1153045 manufactured by Davol Inc., Sub. C.r. Bard, Inc..

MAUDE Entry Details

• Report Number: 1213643-2019-06033
• MDR Report Key: 8789523
• Report Source: HEALTH PROFESSIONAL,OTHER,STU
• Date Received: 2019-07-15
• Date of Report: 2019-07-15
• Date of Event: 2019-05-30
• Date Mfgr Received: 2019-07-02
• Date Added to Maude: 2019-07-15
• 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: 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: XENMATRIX AB
• Generic Name: PORCINE SURGICAL MESH
• Product Code: PIJ
• Date Received: 2019-07-15
• Model Number: NA
• Catalog Number: 1153045
• Lot Number: HUBP2070
• Device Expiration Date: 2019-02-28
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• 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		2019-07-15