MAUDE Adverse Event Report: BARD BARD PHARM.; MESH

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Adhesion(s) (1695); Pain (1994); No Code Available (3191)

Event Date 01/01/1994

Event Type  Injury  

Event Description

I was only (b)(6).I have permanent damage and impairment.I have gone down to (b)(6).I never knew that it was (vaginal mesh) put inside me.I was never told.I have never signed anything for an experimental device put inside me.I had severe prolapse of uterus and bladder after given birth to my 5th love child.(b)(6) of 1994 dr said she would take out my uterus (partial hysterectomy) and tack up my bladder.I would be like new again.Problems: did not know about vaginal mesh, the vaginal mesh was killing me.I didn't know this.I had outside air going inside my body because the mesh ate my entire vaginal "wall" and vagina.Vaginal mesh attached to everything it touched and was eating away on those tissues.This is my medical records that you can have all of it with my permission.(b)(6).Specialist 1996, (b)(6); he told me that, if he didn't operate on me tomorrow, i would die within the week.The vaginal mesh has been a life changing event.My health is still affected by this stuff, after the big operation of 1996, i have had more operations to remove more mesh.They left 2 instrument inside me and my intestine are severely affected.I have severe adhesions everywhere with my gort.My pelvic floor is in constant pain.The pain is like if i rubbed chilli peppers into my eyes.It's like chilli pepper are being rubbed by my pelvic floor.I could give you more info if you need it.I was used as a "ginny" pig without my knowledge.Two years before it was ever accepted to put this 'crap' into me.I feel used, abused and "disgusted" if i had died nobody would have been the "wiser.".

• Brand Name: BARD PHARM.
• Type of Device: MESH
• Manufacturer (Section D): BARD
• MDR Report Key: 6089534
• MDR Text Key: 59714083
• Report Number: MW5065920
• Device Sequence Number: 1
• Product Code: FTL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 36 YR
• Patient Weight: 107