MAUDE Adverse Event Report: HERNIAMESH SRL T-SLING

Model Number CAL-TS05

Device Problem Insufficient Information (3190)

Patient Problems Incontinence (1928); Muscle Spasm(s) (1966); Nerve Damage (1979); Pain (1994); Sepsis (2067); Swelling (2091); Cramp(s) (2193); Hernia (2240); Numbness (2415)

Event Date 09/20/2007

Event Type  Injury  

Event Description

The patient was implanted with a herniamesh t-sling ts-05 lot 0359 on (b)(6) 2007 the patient has suffered has suffered severe pelvic pain, swelling, cramping, numbness, worsened incontinence, vaginal and rectal spasms, mrsa, pyoderma, gangranosa, an abdominal hernia, and nerve damage since mesh implantation.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: 5395345
• MDR Text Key: 36955666
• Report Number: 9614846-2016-00004
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 03/27/2011
• Device Model Number: CAL-TS05
• Device Lot Number: 0356
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/15/2015
• Initial Date FDA Received: 01/28/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/27/2006
• 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