• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION XENFORM MESH, SURGICAL, NON-SYNTHETIC, UROGYNECOLOGIC FOR APICAL VAGINAL AND UTERINE PRO

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC CORPORATION XENFORM MESH, SURGICAL, NON-SYNTHETIC, UROGYNECOLOGIC FOR APICAL VAGINAL AND UTERINE PRO Back to Search Results
Model Number M0068302470
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abnormal Vaginal Discharge (2123); Prolapse (2475)
Event Date 03/01/2017
Event Type  Injury  
Manufacturer Narrative
The complete patient identifier is (b)(6). (b)(4). Report source: study name: (b)(6). The complainant indicated that the device is implanted and will not 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 medwatch will be filed.
 
Event Description
It was reported to boston scientific corporation that a xenform graft material device was implanted during a pelvic floor reconstruction with xenform including apical vault suspension & cystocele repair procedure performed on (b)(4) 2015. According to the complainant, on (b)(6) 2017, the subject experienced atypical vaginal discharge. She was treated with metrogel vaginal cream and the event resolved on (b)(6) 2017. The investigator assessed the event as mild in severity, pelvic floor related, possibly related to the procedure, and possibly related to the device.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameXENFORM
Type of DeviceMESH, SURGICAL, NON-SYNTHETIC, UROGYNECOLOGIC FOR APICAL VAGINAL AND UTERINE PRO
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
TEI BIOSCIENCES INCORPORATED
7 elkins street
boston MA 02127
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key8374080
MDR Text Key137271037
Report Number3005099803-2019-00998
Device Sequence Number1
Product Code FTM
UDI-Device Identifier08714729774198
UDI-Public08714729774198
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K060984
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 02/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/27/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/31/2017
Device Model NumberM0068302470
Device Catalogue Number72920
Device Lot Number0001506003
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/30/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/30/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/27/2019 Patient Sequence Number: 1
-
-