MAUDE Adverse Event Report: HERNIAMESH SRL T-SLING

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Abrasion (1689); Erosion (1750); Edema (1820); Hemorrhage/Bleeding (1888); Laceration(s) (1946); Pain (1994); Perforation (2001); Scarring (2061); Disability (2371); Dysuria (2684)

Event Date 02/18/2015

Event Type  Injury  

Event Description

Patient has suffered excruciating pain, laceration/perforation of internal bodily tissue and organs, erosion/abrasion/grating of internal bodily tissue and organs, severe dyspareunia severe dysuria, severe edema, extrusion of the subject products, internal bleeding, permanent scarring, permanent bodily impairment and related sequelae necessitating revision/corrective surgeries and resulting in substantial interference with enjoyment of life.No further information has been provided.

• Brand Name: T-SLING
• Type of Device: 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: 5463924
• MDR Text Key: 39153069
• Report Number: 9614846-2016-00012
• 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: 02/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/15/2015
• Initial Date FDA Received: 02/26/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other