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

Catalog Number UNKNOWN

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

Patient Problems Pain (1994); Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

The reported event could not be confirmed.The product family and lot number are unknown.No sample was returned for investigation.No review or conclusions could be made regarding the alleged deficiencies.The product family for this women¿s healthcare product is unknown, and no sample was returned for investigation.No review or conclusions could be made regarding the alleged deficiencies.The product family for this women¿s healthcare product is unknown.Therefore, bard is unable to determine the associated labeling to review.Although the product family is unknown, the women¿s health product ifus are found to be adequate based on past reviews.

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, and impairment.

• Brand Name: UNKNOWN WOMENS HEALTH PRODUCT
• Type of Device: UNKNOWN WOMENS HEALTH PRODUCT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON); 8195 industrial blvd.; covington GA 30014
• Manufacturer Contact: juan velez ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 15292922
• MDR Text Key: 298578556
• Report Number: 1018233-2022-90025
• 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: 08/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2022
• 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
• Date Manufacturer Received: 08/11/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Female