MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 AVAULTA SOLO ANTERIOR SYNTHETIC SUPPORT SYSTEM; OTP

Catalog Number 486100

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Injury (2348); Numbness (2415)

Event Type  Injury  

Event Description

The patient's attorney alleged a deficiency against the device.Per additional information received, the patient has experienced "lower extremity numbness and stiffness most likely due to the lithotomy position during her surgical procedure," "one temperature of 100.9 on postoperative zero likely due to atelectasis," unspecified pain, unspecified bowel problems, "recurrence," and dyspareunia.

Manufacturer Narrative

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).The total number of events for product classification code otp is (b)(4).Qty (b)(4) - avaulta plus biosynthetic support system; qty (b)(4 )- avaulta plus biosynthetic support system - anterior, sterile; qty (b)(4) - avaulta plus biosynthetic support system - posterior, sterile; qty (b)(4) - avaulta solo synthetic support system - anterior, sterile; qty (b)(4) - avaulta solo synthetic support system - posterior, sterile; qty (b)(4) - unknown bmd women's health product.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(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.(b)(4).

Manufacturer Narrative

(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.(b)(4).

Manufacturer Narrative

(b)(4).Original reporting time frame (b)(6) 2015.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).

Manufacturer Narrative

(b)(4).Original reporting time frame november 1, 2014 through january 31, 2015.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.

Manufacturer Narrative

Exemption no.(b)(4).Original reporting time frame november 1, 2014 to january 31, 2015.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.

Manufacturer Narrative

(b)(4).Original reporting time frame november 1, 2014 to january 31, 2015.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.

Manufacturer Narrative

(b)(4).Original reporting time frame november 1, 2014 to january 31, 2015.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.

Manufacturer Narrative

(b)(4).Original reporting time frame november 1, 2014 to january 31, 2015.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.

Manufacturer Narrative

(b)(4).Original reporting time frame (b)(6) 2014 to (b)(6) 2015.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.

Manufacturer Narrative

(b)(4).Original reporting time frame november 1, 2014 to january 31, 2015.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.

Manufacturer Narrative

(b)(4).Original reporting time frame november 1, 2014 to january 31, 2015.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.

Manufacturer Narrative

(b)(4).Original reporting time frame november 1, 2014 to january 31, 2015.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.

Manufacturer Narrative

(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.

Manufacturer Narrative

(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.

Manufacturer Narrative

(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.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Exemption no.(b)(4).Original reporting time frame november 1, 2014 to january 31, 2015.The information provided by bd represents all of the known information at this time.

Manufacturer Narrative

Exemption no.(b)(4) original reporting time frame november 1, 2014 to january 31, 2015.The information provided by bd represents all of the known information at this time.

Manufacturer Narrative

Exemption no.(b)(4).Original reporting time frame november 1, 2014 to january 31, 2015.The information provided by bard represents all of the known information at this time.

Manufacturer Narrative

Exemption no.(b)(4).Original reporting time frame november 1, 2014 to january 31, 2015.The information provided by bard represents all of the known information at this time.

Manufacturer Narrative

Exemption no.(b)(4).Original reporting time frame november 1, 2014 to january 31, 2015.The information provided by bard represents all of the known information at this time.

Manufacturer Narrative

Exemption no.(b)(4).Original reporting time frame november 1, 2014 to january 31, 2015.The information provided by bard represents all of the known information at this time.

• Brand Name: AVAULTA SOLO ANTERIOR SYNTHETIC SUPPORT SYSTEM
• Type of Device: OTP
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; lot #1, road #3, km 79.7; covington GA 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; lot #1, road #3, km 79.7; covington GA 30014
• Manufacturer Contact: angela robinson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 4555253
• MDR Text Key: 5472600
• Report Number: 1018233-2015-00055
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082571
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,other
• Reporter Occupation: Attorney
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2010
• Device Catalogue Number: 486100
• Device Lot Number: HUSG1037
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Device Age: 5 MO
• Event Location: Hospital
• Date Manufacturer Received: 10/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 89