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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 Migration (4003)
Patient Problems Erosion (1750); Micturition Urgency (1871); Incontinence (1928); Inflammation (1932); Urinary Retention (2119); Abnormal Vaginal Discharge (2123)
Event Date 01/15/2015
Event Type  Injury  
Event Description
It was reported that a patient underwent a sling procedure on an unknown date and mesh was implanted.The patient experienced urge incontinence, retention/slow flow during urination, pain during intercourse, vaginal discharge, inflammation and erosion of mesh in vaginal wall.As a result, the implant was explanted due to ongoing complications.No further information is available as reporter details have not been disclosed (confidential).
 
Manufacturer Narrative
(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.To date it has been reported that the device will not be returned.If the device or further details are received at a later date a supplemental medwatch will be sent.H6 component code: g07002 ¿ device not returned.
 
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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
Manufacturer (Section G)
ETHICON SARL-NEUCHATEL
puits-godet 20
neuchatel 2000
SZ   2000
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
9083863534
MDR Report Key18924500
MDR Text Key337911700
Report Number2210968-2024-03143
Device Sequence Number1
Product Code OTN
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K974098
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign
Reporter Occupation Other
Type of Report Initial
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 03/13/2024
Initial Date FDA Received03/18/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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