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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: XENFORM BOVINE MATRIX ; MESH, SURGICAL, NON-SYNTHETIC, UROGYNECOLOGIC, FOR APICAL VAGINAL AND UTERINE PR
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XENFORM BOVINE MATRIX ; MESH, SURGICAL, NON-SYNTHETIC, UROGYNECOLOGIC, FOR APICAL VAGINAL AND UTERINE PR Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pain (1994)
Event Date 12/30/2010
Event Type  Injury  
Event Description
Had a rectocele and enterocele repair on (b)(6) 2010.My surgeon used xenform bovine matrix.I had a severe rectocele and had difficulty with bowel movements, but no pain other than bladder pain.I had not had tailbone pain prior to surgery.Immediately after surgery and the following years to present time, i have pain sitting after only a few minutes which becomes severe after 15 to 20 minutes.I have pain standing and walking.I have rectal, buttock and vaginal pain.I have pain with intercourse.I could not return to work after surgery and am on social disability.My family and social life are greatly reduced.I am unable to exercise or live a normal life.My family, friends, and church have all been impacted as a result.I am greatly limited in the amount of activity i can endure and spend a great deal of the day lying down.My whole life has changed for the worse.I deeply regret having this surgery.Pelvic organ prolapse.
 
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Brand Name
XENFORM BOVINE MATRIX
Type of Device
MESH, SURGICAL, NON-SYNTHETIC, UROGYNECOLOGIC, FOR APICAL VAGINAL AND UTERINE PR
MDR Report Key9526232
MDR Text Key173235951
Report NumberMW5091925
Device Sequence Number1
Product Code PAJ
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 12/23/2019
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 No Information
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/26/2019
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Disability;
Patient Age48 YR
Patient Weight62
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