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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 M0068302450
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Edema (1820); Pain (1994); Swelling (2091); Disability (2371)
Event Date 06/29/2016
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. Tga device incident report reference no (b)(4); submitted to tga (therapeutic goods administration) by the patient. (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 a xenform tissue repair matrix was implanted into the patient during a prolapse procedure performed on (b)(6) 2016 for the treatment of prolapse. According to the patient, after the procedure, the patient has experienced large swelling/edema that is obvious in a large square shape around the patient's tailbone region/lower spine. Reportedly, the patient's tailbone would ache and sting after sitting for longer than 30 minutes. In addition, the patient is unable to lift more than 3kg again and is only able to sleep on back. Subsequently, the patient takes mersyndal forte or mersyndal capets to help with pain in the nighttime and is also on antidepressants, trialled lyrica for pain, and gabapentin and beta blockers plus mobic and somac to help with pain and swelling. The patient also regularly sees a clinical therapist since her prolapse surgery. 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 Key10900265
MDR Text Key218245157
Report Number3005099803-2020-05630
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
PMA/PMN Number
K060984
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial
Report Date 11/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/25/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberM0068302450
Device Catalogue Number830-245
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/24/2018
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: 11/25/2020 Patient Sequence Number: 1
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