MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 AVAULTA PLUS

Catalog Number UNKNOWN

Device Problems Patient-Device Incompatibility (2682); Material Protrusion/Extrusion (2979)

Patient Problems Abdominal Pain (1685); Erosion (1750); Cyst(s) (1800); Diarrhea (1811); Headache (1880); Unspecified Infection (1930); Internal Organ Perforation (1987); Pain (1994); Perforation (2001); Raynauds Phenomenon (2034); Scar Tissue (2060); Skin Discoloration (2074); Weakness (2145); Burning Sensation (2146); Complaint, Ill-Defined (2331); Sweating (2444); Hematuria (2558); Weight Changes (2607); Heavier Menses (2666)

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The device was not returned.

Event Description

It was reported that a patient allegedly had the bladder perforated with one of the anchors of an avaulta plus device during placement.It is also noted that the sling was placed so tight that the bladder was not able to work properly.The patient claimed that she immediately became dependent on catheters.The patient had to have a revision to cut the sling.The patient had a partial removal of the sling which did not help.The patient became very sick within a few months and noted that every part of her body began to hurt.The patient reported losing 40 lbs.And her skin started to burn.Her muscles have started throbbing and she now has weakness which prevents her from walking very far.Her bones ache and bladder spasms have been constant.She was diagnosed with interstitial cystitis in the bladder and had a cyst in the bladder along with fibromyalgia.She had an additional 2 surgeries to attempt removal of the tvt sling.The anchors were not able to be removed and the mesh that was removed was covered with dark colored scar tissue.Nine years later, the patient still has pieces of the mesh being expelled through the vaginal wall.Her urinalysis always shows blood in her urine, and an infection.Sex became too painful.The mesh that protruded through the vaginal wall has cut the penis of her ex husbands.That piece of mesh was excised in the doctor's office days later.Her vagina bleeds often and she has constant diarrhea and ibs symptoms.She also experiences constant headaches, severe sweating of the hands and feet.Dark patches have begun appearing on her face.She has raynauds syndrome and restless legs syndrome.She also has potts disease.Polyps showed up in her nose and secondary colon.She has bones in her spine that are degenerating.She has lost all her teeth.She has pleurisy.She fights to keep her weight above 100 lbs.An interstim was placed in the bladder to help control pain.

Manufacturer Narrative

The device was not returned for evaluation.The lot number is unknown; therefore, a device history record could not be reviewed.Although the product family is unknown, the bard avaulta product ifus are found to be adequate based on past reviews.The device was not returned.

Event Description

It was reported that a patient allegedly had the bladder perforated with one of the anchors of an avaulta plus device during placement.It was also noted that the sling was placed so tight that the bladder was not able to work properly.The patient claimed that she immediately became dependent on catheters.The patient had to have a revision to cut the sling.The patient had a partial removal of the sling which did not help.The patient became very sick within a few months and noted that every part of her body began to hurt.The patient reported losing 40 lbs.And her skin started to burn.Her muscles have started throbbing and she now has weakness, which prevents her from walking very far.Her bones ache and bladder spasms have been constant.She was diagnosed with interstitial cystitis in the bladder and had a cyst in the bladder along with fibromyalgia.She had an additional 2 surgeries to attempt removal of the tvt sling.The anchors were not able to be removed and the mesh that was removed was covered with dark colored scar tissue.Nine years later, the patient still had pieces of the mesh being expelled through the vaginal wall.Her urinalysis always shows blood in her urine, and an infection.Sex became too painful.The mesh that protruded through the vaginal wall has cut the penis of her ex husbands.That piece of mesh was excised in the doctor's office days later.Her vagina bled often and she had constant diarrhea and ibs symptoms.She also experienced constant headaches, severe sweating of the hands and feet.Dark patches have begun appearing on her face.She has raynauds syndrome and restless legs syndrome.She also has potts disease.Polyps showed up in her nose and secondary colon.She had bones in her spine that were degenerating and lost all her teeth.She had pleurisy.She fights to keep her weight above 100 lbs.An interstim was placed in the bladder to help control pain.

• Brand Name: AVAULTA PLUS
• Type of Device: AVAULTA PLUS
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7589472
• MDR Text Key: 110712643
• Report Number: 1018233-2018-02173
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• PMA/PMN Number: K083839
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 07/09/2018

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/22/2018
• Initial Date FDA Received: 06/11/2018
• Supplement Dates Manufacturer Received: 06/27/2018
• Supplement Dates FDA Received: 07/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability