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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. GYNECARE PROLIFT+M POSTERIOR; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
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ETHICON INC. GYNECARE PROLIFT+M POSTERIOR; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC Back to Search Results
Catalog Number PFRP02
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Pain (1994); Scarring (2061)
Event Type  Injury  
Manufacturer Narrative
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 by an attorney that the patient underwent a posterior mesh repair surgical procedure on (b)(6) 2010 and mesh was implanted.It was reported that the patient experienced urinary problems, dyspareunia, pelvic pain, scarring, pain in buttocks and legs, vaginal infection and lower backache.No additional information was provided.
 
Manufacturer Narrative
Date sent to fda: 4/23/2020.Additional information: d4, h4.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
 
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Brand Name
GYNECARE PROLIFT+M POSTERIOR
Type of Device
MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876
MDR Report Key9969630
MDR Text Key193086300
Report Number2210968-2020-03076
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 foreign,other
Type of Report Initial,Followup
Report Date 04/15/2020
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 Expiration Date04/30/2012
Device Catalogue NumberPFRP02
Device Lot Number3371571
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/15/2020
Initial Date FDA Received04/16/2020
Supplement Dates Manufacturer Received04/17/2020
Supplement Dates FDA Received04/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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