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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION XENOGRAFT PELVIC FLOOR GRAFT; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR APICAL VAGINAL AND UTERINE PROLAP

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BOSTON SCIENTIFIC CORPORATION XENOGRAFT PELVIC FLOOR GRAFT; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR APICAL VAGINAL AND UTERINE PROLAP Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Prolapse (2475)
Event Type  No Answer Provided  
Event Description
I am looking for information on cook surgisis pelvic floor graft and boston scientific xenograft for pelvic floor gynecological use.I have both of these products inserted for pelvic organ prolapse & have recurring infections and other health problems since implantation.I am in (b)(6) the gynecologist who implanted these products is no longer practicing.I have not been able to get assistance or answers from other gynecologists as to whether either of these products could be causing my health problems.I am not able to get a referral to infectious disease specialist.I would appreciate any information on these products particularly any infections or shrinkage these products may cause.Cpt2101662, cpt2101664.
 
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Brand Name
XENOGRAFT PELVIC FLOOR GRAFT
Type of Device
MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR APICAL VAGINAL AND UTERINE PROLAP
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
MDR Report Key12711216
MDR Text Key279275291
Report NumberMW5104980
Device Sequence Number2
Product Code OTO
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Type of Report Initial
Report Date 10/07/2021
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received10/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator No Information
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
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