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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Incontinence (1928); Scar Tissue (2060); Urinary Retention (2119); Prolapse (2475); No Code Available (3191)
Event Date 06/24/2010
Event Type  Injury  
Manufacturer Narrative
The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown. (b)(4). The complainant indicated that the device is implanted and 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 a xenform graft material device was implanted into the patient during a procedure performed on (b)(6) 2006. As reported by the patient's attorney, the patient underwent implantation of a non - boston scientific device, cystoscopy and examination on (b)(6) 2010 due to stress urinary incontinence, cystocele, vaginal scarring and urinary retention. Boston scientific has been unable to obtain additional information regarding the event to date.
 
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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 Key9835899
MDR Text Key189582012
Report Number3005099803-2020-00938
Device Sequence Number1
Product Code FTM
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
Type of Report Initial
Report Date 03/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/19/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/16/2020 Patient Sequence Number: 1
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