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

Catalog Number UNKNOWN

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

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

No sample received.

Event Description

The patient's attorney alleged a deficiency against the device.

• Brand Name: PELVICOL® ACELLULAR COLLAGEN MATRIX
• Type of Device: PELVICOL® ACELLULAR COLLAGEN MATRIX
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 12882210
• MDR Text Key: 281325448
• Report Number: 1018233-2021-80096
• Device Sequence Number: 1
• Product Code: PAG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/29/2021

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
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/19/2021
• Initial Date FDA Received: 11/29/2021
• 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; PELVISOFT® ACELLULAR COLLAGEN BIOMESH
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 82 KG