MAUDE Adverse Event Report: TEI BIOSCIENCES INCORPORATED 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 Problem Unspecified Infection (1930)

Event Date 03/01/2018

Event Type  Injury  

Manufacturer Narrative

Patient identifier is (b)(4).Study name: u9920 xenform a/a postmarket.The device is implanted and not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental report will be filed.

Event Description

It was reported to boston scientific corporation that a xenform soft tissue repair matrix was implanted in the patient on (b)(6) 2016.According to the complainant, on (b)(6) 2018, the patient experienced urinary tract infection.She was treated with antibiotics and the event resolved on (b)(6) 2018.

• Brand Name: XENFORM SOFT TISSUE REPAIR MATRIX
• Type of Device: MESH, SURGICAL, NON-SYNTHETIC, UROGYNECOLOGIC FOR APICAL VAGINAL AND UTERINE PRO
• Manufacturer (Section D): TEI BIOSCIENCES INCORPORATED; 7 elkins street; boston MA 02127
• 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: 7424534
• MDR Text Key: 105237885
• Report Number: 3005099803-2018-00963
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/19/2018

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: Physician
• Device Expiration Date: 07/31/2018
• Device Model Number: M0068302470
• Device Lot Number: 0001510026
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/19/2018
• Initial Date FDA Received: 04/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 64