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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 Erosion (1750); Incontinence (1928); Pain (1994); Discomfort (2330); Disability (2371); No Code Available (3191); Urinary Incontinence (4572)
Event Date 09/20/2017
Event Type  Injury  
Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown. This was reported by the patient's legal representation. The device surgeon is: (b)(6). (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
Note: this report pertains to one of two devices used during the same procedure. It was reported to boston scientific corporation that a xenform device was implanted during a xenform procedure between around (b)(6) 2017 to around (b)(6) 2018 to treat vaginal prolapse. As reported by the patient's attorney, after the implantation, the patient has suffered from injuries and disabilities. The personal injury alleged to have been suffered by the patient includes urinary incontinence, urethral erosion/damage, requirement for subsequent procedures including cystoscopies, pudendal blocks, botox injections, excision of the mesh from urethra, chronic and relenting pain together with symptoms arising therefrom. Reportedly, the patient underwent the surgical intervention on (b)(6) 2017 and had further procedures for treatment and mesh removal on (b)(6) 2018. 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
elkins street
boston MA 02127
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key10564790
MDR Text Key207952100
Report Number3005099803-2020-03905
Device Sequence Number1
Product Code FTM
UDI-Device Identifier08714729774198
UDI-Public08714729774198
Combination Product (y/n)N
Reporter Country CodeAS
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,Followup
Report Date 03/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberM0068302470
Device Catalogue Number72920
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/02/2021
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: 09/21/2020 Patient Sequence Number: 1
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