MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MARLBOROUGH XENFORM SOFT TISSUE REPAIR MATRIX; MESH, SURGICAL, NON-SYNTHETIC, UROGYNECOLOGIC FOR APICAL VAGINAL AND UTERINE PRO

Model Number M0068302470

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Fistula (1862); Unspecified Infection (1930); Nerve Damage (1979); Internal Organ Perforation (1987); Pain (1994); Scar Tissue (2060)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

As reported by the patient's attorney, a boston scientific device was implanted.According to the complainant, the patient experienced erosion, mesh contraction, infection, fistula, inflammation, scar tissue, organ perforation, dyspareunia, blood loss, neuropathic and other acute and chronic nerve damage and pain, pudendal nerve damage, pelvic floor damage, chronic pain, operations to locate and remove mesh, operations to attempt to repair pelvic organs, tissue and nerve damage, the use of pain control and other mediations, injections into various areas of the pelvis spine and the vagina and operations to remove portions of the female genitalia.All other information is unknown.Should additional relevant details become available, a supplemental report will be submitted.

• Brand Name: XENFORM SOFT TISSUE REPAIR MATRIX
• Type of Device: MESH, SURGICAL, NON-SYNTHETIC, UROGYNECOLOGIC FOR APICAL VAGINAL AND UTERINE PRO
• Manufacturer (Section D): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): TEI BIOSCIENCES INCORPORATED; 7 elkins street; boston MA 02127
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 5787426
• MDR Text Key: 49362992
• Report Number: 3005099803-2016-01984
• Device Sequence Number: 1
• Product Code: PAJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060984
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2011
• Device Model Number: M0068302470
• Device Lot Number: 0000909012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/24/2016
• Initial Date FDA Received: 07/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention