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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PROLENE MESH 15X15CM MESH, SURGICAL, POLYMERIC

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ETHICON INC. PROLENE MESH 15X15CM MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number PMM3
Device Problem Migration (4003)
Patient Problems Erosion (1750); Abnormal Vaginal Discharge (2123); Blood Loss (2597); Not Applicable (3189)
Event Type  Injury  
Manufacturer Narrative

(b)(4). To date the device has not been returned. If the device or further details are received at the later date a supplemental medwatch will be sent. Attempts are being made to obtain the additional information. To date no response has been provided. If further details are received at the later date a supplemental medwatch will be sent. The patient demographic info: age, weight, bmi at the time of index procedure. Other relevant patient history/concomitant medications. The initial approach for the index surgical procedure in 2011? any concurrent procedure/device implantation? were there any intra-operative complications? onset date of current symptoms (recurrence of prolapse, vaginal discharge and bleeding) from initial surgery? when was the mesh exposure first noted by a physician? describe any medical/surgical intervention for exposure and recurrent prolapse including dates and surgical findings. What is physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status?.

 
Event Description

It was reported that patient underwent an abdominal hysterectomy and sacrocolpopexy in 2011 for prolapse and the mesh was implanted. The patient developed a recurrence of prolapse and vaginal discharge with some bleeding which was noticed recently. Clinically patient has a mesh erosion at the vault. An mri and discussion at mdt has been arranged. Patient will require mesh excision at some date in the future. Additional information has been requested.

 
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Brand NamePROLENE MESH 15X15CM
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
Manufacturer (Section G)
ETHICON INC.-SAN LORENZO PR
982 road 183 km 8.3
san lorenzo PR
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key8215239
MDR Text Key132040181
Report Number2210968-2019-78162
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
PMA/PMN NumberK962530
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,O
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/19/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/03/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/31/2014
Device Catalogue NumberPMM3
Device LOT NumberBAB223
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/24/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/08/2009
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 01/03/2019 Patient Sequence Number: 1
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