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

Catalog Number 486200

Device Problems Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); No Known Impact Or Consequence To Patient (2692)

Event Date 04/27/2020

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Event Description

It was reported that the mesh inserted got eroded and was removed.

Event Description

It was reported that the mesh inserted got eroded and was removed.

Manufacturer Narrative

The reported event was inconclusive.The sample was not returned for evaluation.The finished product met all specifications prior to being released for general distribution.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.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 events: ¿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.1750 = "l" h11:section a through f - 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.H3 other text : the device was not returned.

• Brand Name: AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM - POSTERIOR
• Type of Device: AVAULTA SOLO® SYNTHETIC SUPPORT SYSTEM - POSTERIOR
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10493457
• MDR Text Key: 205657530
• Report Number: 1018233-2020-05680
• Device Sequence Number: 1
• Product Code: OTP
• UDI-Device Identifier: 00801741168031
• UDI-Public: (01)00801741168031
• Combination Product (y/n): N
• PMA/PMN Number: K082571
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2013
• Device Catalogue Number: 486200
• Device Lot Number: HUVC1859
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR