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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
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ETHICON INC. PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC Back to Search Results
Catalog Number PROLIFTUNK
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Hemorrhage/Bleeding (1888); Pain (1994)
Event Type  Injury  
Event Description
It was reported that the patient underwent a gynecological surgical procedure on (b)(6) 2006 and prolift was implanted.It was reported that the patient experienced pain, dyspareunia, bleeding and voiding dysfunction and underwent removal surgery on (b)(6) 2016.No additional information was provided.
 
Manufacturer Narrative
This emdr represents supplemental report # (b)(4) for previously submitted mdr number 2210968-2018-75205, subject of a litigation complaint summary exemption no.E2013037.The referenced exemption was revoked effective may 15, 2019.To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation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.
 
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Brand Name
PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT
Type of Device
MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
Manufacturer (Section D)
ETHICON INC.
1000 route 202
raritan NJ 08869
MDR Report Key12741409
MDR Text Key284697718
Report Number2210968-2021-10702
Device Sequence Number1
Product Code OTP
Combination Product (y/n)N
PMA/PMN Number
K013718
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial
Report Date 11/02/2021
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 NumberPROLIFTUNK
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/27/2019
Initial Date FDA Received11/02/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age44 YR
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