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

Catalog Number 482812

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

Patient Problems Micturition Urgency (1871); Injury (2348)

Event Type  Injury  

Event Description

The patient's attorney alleged a deficiency against the device.Per additional information received the patient has experienced difficulty with bowel movements, occasional urgency, protective pad use, and required nonsurgical interventions.

• 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: 8830469
• MDR Text Key: 152325008
• Report Number: 1018233-2019-04236
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/25/2019,07/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/12/2010
• Device Catalogue Number: 482812
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/25/2019
• Distributor Facility Aware Date: 07/10/2019
• Event Location: Hospital
• Date Report to Manufacturer: 07/25/2019
• Date Manufacturer Received: 07/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ALIGN TO URETHRAL SUPPORT SYSTEM HOOK
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 79