MAUDE Adverse Event Report: ETHICON SARL GYNECARE TVT EXACT CONTINENCE SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Catalog Number TVTRL

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Bruise/Contusion (1754); Micturition Urgency (1871); Incontinence (1928); Unspecified Infection (1930); Inflammation (1932); Nerve Damage (1979); Pain (1994); Swelling (2091); Urinary Retention (2119); Urinary Frequency (2275); Injury (2348); Obstruction/Occlusion (2422); Ambulation Difficulties (2544); No Code Available (3191)

Event Date 10/31/2016

Event Type  Injury  

Manufacturer Narrative

(b)(6).Catheter dependent.Recurrent incontinence occurred, obstruction occurred.The review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.

Event Description

It was reported that the patient underwent an unknown gynecological procedure on unknown date and the mesh was implanted to the retro-pubic area.After the procedure, the patient experienced a wound infection, sciatic nerve damage, trauma to pelvic area resulting in acute pain and causing severe bruising and swelling and suspected femoral nerve damage.Since the surgery, the patient experienced pain, discomfort, anxiety and bladder problems.It was also reported that the patient must depend on others to do household chores, picking up their grandchild, to have sex due to discomfort and fear of penetration.The urinary stress incontinence has returned and the patient must to wear protection.The patient was unable to void and remained catheter dependent four weeks.As reported, the bladder never returned to normal function.The patient is also experiencing hip and thigh pain/discomfort, inflammation, sharp stabbing vaginal pain and voiding dysfunction included frequency, urgency, hesitation and numbness that must look to see if flow stops or accidents occur.The movement is restricted and the patient shuffle until they gain momentum.Sciatic nerve goes into spasm with excruciating pain radiated into hip and down leg.The stream is weak and the patient must stand to enhance flow, if they sit flow stops.Sometimes urgency makes the patient rush to the bathroom when bladder is full, but when the patient gets there, no voiding occurred.The patient must force and clench muscles to void and empty bladder.The doctor opined that the mesh is causing obstruction and needs to be cut.The patient is looking for the mesh to be removed.Additional information has been requested.

• Brand Name: GYNECARE TVT EXACT CONTINENCE SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON SARL; puits-godet 20; neuchatel 2000 ; SZ 2000
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20; neuchatel 2000 ; SZ 2000
• Manufacturer Contact: darlene kyle ; route 22 west po box 151; somerville, NJ 08876 ; 9082182792
• MDR Report Key: 6798826
• MDR Text Key: 82859047
• Report Number: 2210968-2017-04764
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K132054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2016
• Device Catalogue Number: TVTRL
• Device Lot Number: 3884276
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR