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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 Abscess (1690); Erosion (1750); Purulent Discharge (1812); Unspecified Infection (1930); Abnormal Vaginal Discharge (2123); Blood Loss (2597)
Event Type  Injury  
Manufacturer Narrative

(b)(4). The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot. Additional information was requested and the following was obtained: 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? (b)(6)/bmi not known/abdominal sacrocolpopexy followed by a vaginal repair a year later. Any concurrent procedure/device implantation? no. Were there any intra-operative complications? none ¿ repeat surgery not done yet. Onset date of current symptoms (recurrence of prolapse, vaginal discharge and bleeding) from initial surgery? within 12 months of surgery. When was the mesh exposure first noted by a physician? when she attended my clinic recently although she has been attending the pessary clinic and seen other colleagues with similar problems over the years. Describe any medical/surgical intervention for exposure and recurrent prolapse including dates and surgical findings. Will need total excision in due course. Discussed at our mdt and also had mri which confirms infected mesh with possible abscess cavity. What is physician¿s opinion as to the etiology of or contributing factors to this event what is the patient's current status? mesh presence. Patient is discharging pus vaginally. Adverse event related to vaginal repair performed within 12 months of initial procedure reported via mfr report # 2210968-2019-78162.

 
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. The patient underwent vaginal repair within 12 months of the initial procedure. Discussed at mdt and patient underwent mri which confirmed infected mesh with possible abscess cavity. The patient is discharging pus vaginally. The physician opines there is mesh presence. It was reported that the patient will require full excision in the future. No additional information was provided.

 
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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 00754
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key8339706
MDR Text Key136158201
Report Number2210968-2019-78882
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
Report Date 01/24/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/14/2019
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?
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: 02/14/2019 Patient Sequence Number: 1
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