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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

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ETHICON INC. TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Micturition Urgency (1871); Hematoma (1884); Hemorrhage/Bleeding (1888); Incontinence (1928); Unspecified Infection (1930); Urinary Tract Infection (2120); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 01/01/2001
Event Type  Injury  
Manufacturer Narrative
(b)(4).This report is related to a journal article; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Events related to prolene mesh captured via 2210968-2021-04124.
 
Event Description
Title: long-term results of the tension-free vaginal tape (tvt) procedure for surgical treatment of female stress urinary incontinence.In a prospective long-term nordic multicenter study, 90 consecutive patients who had a tension-free vaginal tape (tvt) operation performed because of stress urinary incontinence were evaluated according to a strict protocol after approximately 5 years (range 4870 months).Eighty-five patients could be evaluated according to the protocol.Another 5 elderly patients had to be interviewed by telephone at the final check-up after 5 years.The study protocol involved pre- and postoperative objective and subjective evaluation.The median followup time was 56 months.All operations were performed under local infiltration anesthesia using 0.25% prilocaine with adrenaline (epinephrine).The tvt (ethicon) set consisted of two 6 mm needles connected to a handle (introducer) and a specific polypropylene prolene(ethicon) mesh tape fixed to the needles.Cystoscopy was performed twice during the operation, after each retropubic pass of the tvt needle(ethicon).Adjustment of the prolene tape  the tension test was performed with the patient coughing repeatedly at a bladder volume of 250300 ml.A few drops of saline were allowed to escape the external meatus of the urethra in order to avoid postoperative retention.Reported complications included incontinence (n=2), surgery failed (n=4), hematoma (n=3), bladder perforation (n=1) ,intraoperative bleeding (n=3), post-operatvie voiding difficulties (n=4) ,urinary tract infection (n=7)-during the first months postoperatively ,infection (n=1), at long term follow-up visit a symptomatic urogenital prolapse grade i (n=2).Recurrent urinary tract infections (n=1), urge symptoms (n=25) and de novo urge symptoms (n=5) in conclusion the tension-free vaginal tape procedure seems to fulfil the expectations of high long-term follow-up cure rates that the short-term results have suggested.Including both subjective and objective criteria for cure or significant improvement, 95% of the tvt-operated women benefited significantly from the operation.The operation, performed under local anesthesia, was well tolerated and was associated with minimal short- and long-term postoperative morbidity.In the light of these good long-term results the tvt operation can be recommended as a routine surgical procedure for the effective treatment of female stress urinary incontinence.
 
Manufacturer Narrative
Date sent to fda: (b)(6) 2021.Corrected: g1 manufacturing site address.This follow up is being submitted to report the manufacturer site address that should have been captured on the initial for mwr-06042021-0000932254.
 
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Brand Name
TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT
Type of Device
MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
Manufacturer (Section D)
ETHICON INC.
1000 route 202
raritan NJ 08869
MDR Report Key11761681
MDR Text Key248612762
Report Number2210968-2021-04125
Device Sequence Number1
Product Code OTN
Combination Product (y/n)N
PMA/PMN Number
K974098
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Type of Report Initial,Followup
Report Date 04/05/2021
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 Health Professional
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/05/2021
Initial Date FDA Received05/03/2021
Supplement Dates Manufacturer Received04/05/2021
Supplement Dates FDA Received05/03/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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