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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

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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 Unspecified Infection (1930); Urinary Retention (2119); Prolapse (2475); No Code Available (3191)
Event Date 03/10/2015
Event Type  Injury  
Manufacturer Narrative
(b)(4).The complaint device is 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 medwatch will be filed.
 
Event Description
It was reported to boston scientific corporation that the patient had recurrent cystocele and recurrent vaginal vault prolapse.She was implanted with a xenform device during a procedure for sacrospinous ligament fixation, with concomitant revision of a previously-implanted non-bsc mesh device.As reported by the patient's attorney, on (b)(6) 2015, the patient underwent a procedure for cystocele repair with native tissue due to recurrent cystocele, recurrent infections, and incomplete bladder emptying.Boston scientific has been unable to obtain additional information regarding the event to date.
 
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Brand Name
XENFORM
Type of Device
MESH, 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)
INTEGRA LIFE SCIENCES SALES LLC
311 enterprise drive
plainsboro NJ 08536
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key9834501
MDR Text Key186615777
Report Number3005099803-2020-01042
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,consum
Reporter Occupation Other
Type of Report Initial
Report Date 03/16/2020
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 Date09/30/2016
Device Model NumberM0068302470
Device Catalogue Number830-247
Device Lot Number0001404014
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/19/2020
Initial Date FDA Received03/16/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/21/2014
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age67 YR
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