AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM - ANTERIOR

Report

Report Number: 1018233-2014-00130
Event Type: Injury
Date Received: May 30, 2014
Report Date: January 14, 2019
Manufacturer: C.R. BARD, INC.
Product Code: OTP
PMA / PMN Number: K082571
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: ATTORNEY

Narratives

Additional Manufacturer Narrative · 1

(B)(4).

Additional Manufacturer Narrative · 1

(B)(4). ORIGINAL REPORTING TIME FRAME (B)(6) 2014. 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. (B)(4).

Additional Manufacturer Narrative · 1

(B)(4). THE SAMPLE WAS NOT RETURNED. THE FINISHED PRODUCT MET ALL SPECIFICATIONS PRIOR TO BEING RELEASED FOR GENERAL DISTRIBUTION. THE INSTRUCTIONS FOR USE WHICH ACCOMPANIES ALL DEVICES CURRENTLY ADDRESSES POTENTIAL RISKS ASSOCIATED WITH SURGICALLY IMPLANTED MATERIALS. THE INSTRUCTIONS FOR USE STATES IN THE ADVERSE REACTIONS: "POTENTIAL ADVERSE REACTIONS ARE THOSE TYPICALLY ASSOCIATED WITH SURGICALLY IMPLANTABLE MATERIALS, INCLUDING HEMATOMA, SEROMA, MUCOSAL OR VISCERAL EROSION, INFECTION, INFLAMMATION, SENSITIZATION, DYSPAREUNIA, SCARIFICATION AND CONTRACTION, FISTULA FORMATION, EXTRUSION AND RECURRENCE OF VAGINAL WALL PROLAPSE. PERFORATIONS OR LACERATIONS OF VESSELS, NERVES, BLADDER, BOWEL, RECTUM, OR ANY VISCERA MAY OCCUR DURING NEEDLE PASSAGE." (B)(4).

Additional Manufacturer Narrative · 1

(B)(4).

Additional Manufacturer Narrative · 1

(B)(4). ORIGINAL REPORTING TIME FRAME MARCH 1, 2014 TO APRIL 30, 2014. 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.

Additional Manufacturer Narrative · 1

EXEMPTION NO. (B)(4). ORIGINAL REPORTING TIME FRAME MARCH 1, 2014 TO APRIL 30, 2014. 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.

Additional Manufacturer Narrative · 1

(B)(4).

Additional Manufacturer Narrative · 1

(B)(4). 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.

Additional Manufacturer Narrative · 1

(B)(4). ORIGINAL REPORTING TIME FRAME MARCH 1, 2014 TO APRIL 30, 2014. 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.

Additional Manufacturer Narrative · 1

(B)(4). ORIGINAL REPORTING TIME FRAME MARCH 1, 2014 TO APRIL 30, 2014. 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.

Additional Manufacturer Narrative · 1

(B)(4). ORIGINAL REPORTING TIME FRAME (B)(4) 2014. 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.

Additional Manufacturer Narrative · 1

(B)(4). ORIGINAL REPORTING TIME FRAME MARCH 1, 2014 TO APRIL 30, 2014. 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.

Additional Manufacturer Narrative · 1

(B)(4). ORIGINAL REPORTING TIME FRAME MARCH 1, 2014 TO APRIL 30, 2014. 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.

Additional Manufacturer Narrative · 1

(B)(4). ORIGINAL REPORTING TIME FRAME MARCH 1, 2014 TO APRIL 30, 2014. 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.

Additional Manufacturer Narrative · 1

(B)(4).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.

Additional Manufacturer Narrative · 1

(B)(4). 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.

Additional Manufacturer Narrative · 1

(B)(4).

Additional Manufacturer Narrative · 1

EXEMPTION: (B)(4). ORIGINAL REPORTING TIME FRAME MARCH 1, 2014 THROUGH APRIL 30, 2014. THE INFORMATION PROVIDED BY BD 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 BD.

Description of Event or Problem · 1

PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED VAGINAL WALL MESH EROSION, WORSENING URINARY INCONTINENCE, CANDIDIASIS OF VULVA AND VAGINA, VAGINAL DRAINAGE/DISCHARGE, PELVIC PAIN, ABDOMINAL TENDERNESS TO PALPATION (RIGHT AND LEFT LOWER QUADRANTS), GRADE 1 RECTOCELE/ENTEROCELE, ATROPHIC VAGINITIS, VAGINAL DRYNESS, DYSPAREUNIA, ABNORMAL PAP SMEAR (EPITHELIAL CELL ABNORMALITY-ATYPICAL SQUAMOUS CELLS OF UNDETERMINED SIGNIFICANCE), UNSPECIFIED PAIN, UNSPECIFIED INFECTION, UNSPECIFIED URINARY PROBLEMS, AND UNSPECIFIED BLEEDING.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
319603	AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM - ANTERIOR	AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM - ANTERIOR	OTP	C.R. BARD, INC.	NA	CVSL0009

Patients

Seq	Age	Sex	Outcome	Treatment
1	54 YR		Required Intervention	THE ARIS TRANS-OBTURATOR TAPE