MAUDE Adverse Event Report: HERNIAMESH SRL T-SLING

Model Number CAL-TS10

Device Problem Extrusion (2934)

Patient Problems Abrasion (1689); Erosion (1750); Edema (1820); Hemorrhage/Bleeding (1888); Laceration(s) (1946); Pain (1994); Scarring (2061); Tissue Damage (2104)

Event Type  Injury  

Event Description

The patient was implanted with a herniamesh t-sling ts-10 lot 0463.The patient has suffered excruciating pain, laceration of and damage to internal bodily tissue and organs, erosion, abrasion and grating or internal bodily tissue and organs, dyspareunia, dysuria, severe edema, extrusion or the subject products, bleeding, permanent scarring.Permanent bodily impairment and related sequelae resulting in substantial interference with the ability to engage in routine daily activities and sporting activities that plaintiffs previously enjoyed.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: 5395344
• MDR Text Key: 36955064
• Report Number: 9614846-2016-00003
• 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: 01/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 01/11/2012
• Device Model Number: CAL-TS10
• Device Lot Number: 0463
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/15/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/25/2007
• 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