MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 PELVISOFT® ACELLULAR COLLAGEN BIOMESH

Catalog Number UNKNOWN

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

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

The reported event could not be confirmed.No sample was returned for evaluation and the lot number is unknown.Based on the investigation findings, current manufacturing controls are considered adequate as to detect and segregate any non-conforming unit.Event described could not be confirmed as a manufacturing related issue.The alleged event is most likely associated with possible procedural/surgical complications.The ifu currently addresses potential risks associated with surgically implantable materials which states the following: precautions pelvisofttm biomesh is for single-patient use only and is to be implanted surgically.If either the outer polyester/polyethylene pouch or the inner foil pouch has been perforated or torn in shipment or storage, then the enclosed pelvisofttm biomesh should not be used.Pelvisofttm biomesh should be hydrated or moist when the package is opened.Dehydrated or dry tissue should not be implanted.Device problem code: (b)(4).

Event Description

The patient's attorney alleged a deficiency against the device.Additional information has been requested, but not yet received.

• Brand Name: PELVISOFT® ACELLULAR COLLAGEN BIOMESH
• Type of Device: PELVISOFT® ACELLULAR COLLAGEN BIOMESH
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 12916025
• MDR Text Key: 281594511
• Report Number: 1018233-2021-80106
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K031332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/02/2021

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/19/2021
• Initial Date FDA Received: 12/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: ALIGN® TO URETHRAL SUPPORT SYSTEM - HALO; AVAULTA PLUS® BIOSYNTHETIC SUPPORT SYSTEM; AVAULTA PLUS® BIOSYNTHETIC SUPPORT SYSTEM-ANTERIOR; PELVICOL® ACELLULAR COLLAGEN MATRIX
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 82 KG