MAUDE Adverse Event Report: HERNIAMESH SRL T-SLING

Model Number CAL-TS10

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

Patient Problems Edema (1820); Hemorrhage/Bleeding (1888); Laceration(s) (1946); Internal Organ Perforation (1987); Pain (1994); Scarring (2061); Injury (2348); Dysuria (2684)

Event Date 07/19/2013

Event Type  Injury  

Event Description

The patient was implanted with a herniamesh t-sling cal-ts10 lot 0466 on date not available many years later 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, bleeding, permanent scarring, permanent bodily impairment and related sequelae.As well as 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: 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: 5465999
• MDR Text Key: 39204393
• Report Number: 9614846-2016-00117
• 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: 02/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 01/10/2012
• Device Model Number: CAL-TS10
• Device Lot Number: 0466
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/01/2013
• Date Device Manufactured: 01/25/2007
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other