MAUDE Adverse Event Report: C. R. BARD, INC. PERFIX PLUG MESH; MESH SURGICAL POLYMERIC

Model Number DNT 13999441/MODL

Device Problem Insufficient Information (3190)

Patient Problems Muscle Spasm(s) (1966); Pain (1994); Numbness (2415); Ambulation Difficulties (2544)

Event Date 01/30/2018

Event Type  Injury  

Event Description

Reporter alleges she experienced severe muscle spasm in her legs a day after being implanted with perfix plug mesh for hernia repair.Reporter advised she was pain free when in bed.However, activities of daily living became hard to accomplish as sitting, standing, walking and general ambulation came with excruciating pain.Lastly, she alleges numbness of lower extremities and continues to experience it even after device explant.

• Brand Name: PERFIX PLUG MESH
• Type of Device: MESH SURGICAL POLYMERIC
• Manufacturer (Section D): C. R. BARD, INC.
• MDR Report Key: 7681120
• MDR Text Key: 113797801
• Report Number: MW5078318
• 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: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: DNT 13999441/MODL
• Device Catalogue Number: 1177920
• Device Lot Number: HUBS 0615
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Weight: 58