MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 UNKNOWN BMD WOMENS HEALTH MESH PRODUCT

Catalog Number UNKNOWN

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

Patient Problems Pain (1994); Injury (2348); Constipation (3274)

Event Type  Injury  

Manufacturer Narrative

The product family for this women¿s health product is unknown; and therefore, the appropriate labeling /product documents for review could not be determined.

Event Description

It was reported by the patient's attorney that as a result of having the product implanted the patient has experienced pain, injury, disability, mental and physical pain, tissue and nerve damage, infection, diverticulitis, mesh erosion, constipation, and required surgical and nonsurgical interventions.

• Brand Name: UNKNOWN BMD WOMENS HEALTH MESH PRODUCT
• Type of Device: UNKNOWN BMD WOMENS HEALTH MESH PRODUCT
• 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: 10390203
• MDR Text Key: 202354799
• Report Number: 1018233-2020-05098
• 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
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2020
• 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
• Date Manufacturer Received: 07/31/2020
• 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: OBTRYX SLING
• Patient Outcome(s): Required Intervention