MAUDE Adverse Event Report: HERNIAMESH S.R.L. T-SLING

Model Number 519400140C

Device Problems Leak/Splash (1354); Material Protrusion/Extrusion (2979)

Patient Problems Wound Dehiscence (1154); Fever (1858); Micturition Urgency (1871); Incontinence (1928); Unspecified Infection (1930); Muscle Spasm(s) (1966); Pain (1994); Urinary Retention (2119); Abnormal Vaginal Discharge (2123); Dysuria (2684)

Event Date 04/15/2011

Event Type  Injury  

Event Description

The pt ws implanted with hernia mesh t-sling and additional sling (mfr unk).Later the pt experienced urinary retention, infected sling, fevers, pelvic pain, recurrent vaginal discharge, tender anterior vaginal sulcus, induration in the right obturator internus muscle, anterior vaginal wall wound dehiscence, suburethral portion of sling exposed, exposure size not noted, spasm type sensation in lower left pelvis, early abscess, shocking sensation down inner part of leg, urinary hesitancy, dysuria, left hip pain, tenderness in left groin, mixed incontinence, severe urge incontinence, pressure, leaking, and spasms.Under general anesthesia, infected and encapsulated suburethral sling removals were performed.

• Brand Name: T-SLING
• Type of Device: NA
• Manufacturer (Section D): HERNIAMESH S.R.L.; 10034 chivasso (to); via f.. 11i, meliga 1/c; meliga ; IT
• Manufacturer Contact: lamberti roberta ; 10034 cguvasso (to); italy via f..11i; meliga 1/c ; IT
• MDR Report Key: 3683214
• MDR Text Key: 16553080
• Report Number: 9614846-2014-00006
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020652
• 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: 02/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2014
• Device Model Number: 519400140C
• Device Lot Number: 2067346
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2009
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR