MAUDE Adverse Event Report: HERNIAMESH SRL T-SLING

Device Problem Extrusion (2934)

Patient Problems Edema (1820); Emotional Changes (1831); Hemorrhage/Bleeding (1888); Laceration(s) (1946); Pain (1994); Scarring (2061); Tissue Damage (2104); Dysuria (2684)

Event Date 02/19/2015

Event Type  Injury  

Event Description

Event was reported to herniamesh by distributor who received the complaint by patient attorney.Legal complaint states that patient suffered excruciating pain, laceration of and damage to internal bodily tissue and organs, erosion, abrasion and grating of internal bodily tissue and organs, dyspareunia, dysuria, severe edema, extrusion of the subject products, bleeding, permanent scarring, permanent bodily impairment and related sequelae resulting in substantial interference with plaintiff's ability to engage in routine daily activities and sporting activities that she previously enjoyed.Defects and failures in the products necessitated several corrective surgeries and may require additional corrective surgeries, continuing treatment and therapies.Further injuries and damages suffered by plaintiff include, but are not limited to, extreme pain and suffering, permanent bodily impairment, mental anguish, loss of enjoyment of life, general damages and special damages.No further information has been provided.

• Brand Name: T-SLING
• Type of Device: T-SLING
• Manufacturer (Section D): HERNIAMESH SRL; via fratelli meliga 1/c; chivasso, torino 10070 ; IT 10070
• Manufacturer (Section G): HERNIAMESH SRL; via fratelli meliga 1/c; chivasso, torino 10070 ; IT 10070
• Manufacturer Contact: selanna martorana ; via fratelli meliga 1/c; chivasso, torino 10070 ; IT 10070 ; 9011919623
• MDR Report Key: 5209821
• MDR Text Key: 30691337
• Report Number: 9614846-2015-00110
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/15/2015
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention