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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. GYNECARE PROLIFT+M ANTERIOR; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
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ETHICON INC. GYNECARE PROLIFT+M ANTERIOR; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC Back to Search Results
Catalog Number PFRA02
Device Problem Migration (4003)
Patient Problems Erosion (1750); Micturition Urgency (1871); Hemorrhage/Bleeding (1888); Pain (1994); Scar Tissue (2060); Urinary Tract Infection (2120); Urinary Frequency (2275)
Event Type  Injury  
Event Description
It was reported that the patient underwent a gynecological surgical procedure on (b)(6) 2010 and prolift+m x2 and tvt-o was implanted.It was reported that the patient experienced pelvic pain, dyspareunia, difficulty voiding, dysuria, frequency, nocturia, urinary tract infections, erosion and migration, bleeding, scarring and urgency.It was reported that the patient underwent removal surgery on (b)(6) 2014.
 
Manufacturer Narrative
This emdr represents supplemental report # (b)(4) for previously submitted mdr number 2210968-2017-01655, subject of a litigation complaint summary exemption no.E2013037.The referenced exemption was revoked effective may 15, 2019.The reports previously submitted as part of the exemption were not submitted in a format compatible with the public mdr database (maude) and are available through fda¿s mdr data files webpage, at https://www.Fda.Gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/mdr-data-files#asr.Therefore, this report does not represent a new reportable event.To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.
 
Manufacturer Narrative
This emdr represents supplemental report # 2210968-2017-01272 for previously submitted mdr number 2210968-2017-01655, subject of a litigation complaint summary exemption no.E2013037.The referenced exemption was revoked effective may 15, 2019.The reports previously submitted as part of the exemption were not submitted in a format compatible with the public mdr database (maude) and are available through fda¿s mdr data files webpage, at https://www.Fda.Gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/mdr-data-files#asr.Therefore, this report does not represent a new reportable event.To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.
 
Event Description
It was reported that the patient underwent a gynecological surgical procedure on (b)(6) 2010 and prolift+m x2 and tvt-o was implanted.It was reported that the patient experienced pelvic pain, dyspareunia, difficulty voiding, dysuria, frequency, nocturia, urinary tract infections, erosion and migration, bleeding, scarring and urgency.It was reported that the patient underwent removal surgery on (b)(6) 2014.
 
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Brand Name
GYNECARE PROLIFT+M ANTERIOR
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
SZ  
Manufacturer Contact
elba bello
1000 route 202
raritan 08869
MDR Report Key12874195
MDR Text Key286002481
Report Number2210968-2021-12096
Device Sequence Number1
Product Code OTP
Combination Product (y/n)N
PMA/PMN Number
K071512
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Other
Type of Report Initial
Report Date 11/25/2021
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
Device Catalogue NumberPFRA02
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/14/2021
Initial Date FDA Received11/25/2021
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
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient SexFemale
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