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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. ULTRAPRO MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC

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ETHICON INC. ULTRAPRO MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Migration (4003)
Patient Problems Erosion (1750); Abnormal Vaginal Discharge (2123)
Event Date 06/07/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4). Attempts are being made to obtain the following information. To date no response has been provided. If further details are received at a later date a supplemental medwatch will be sent. The patient demographic info: age, weight, bmi at the time of index procedure. Date and name of initial surgical procedure. The diagnosis and indication for the initial surgical procedure? what are the patient comorbidities/concomitant medications?   the initial approach for the index surgical procedure? any concurrent procedure/device implantation? were there any intra-operative complications? when was the mesh exposure first noted by a physician? mesh exposure site/location, symptoms and diagnostic confirmation? describe any medical/surgical intervention for exposure including dates and surgical findings. Product lot #. Were cultures or any other diagnostic testing performed for vaginal discharge? 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 a patient underwent an unknown gynecological procedure on an unknown date and the mesh was implanted. It was reported that the patient experienced a localized exposure of mesh and foul smelling vaginal discharge. Additional information has been requested.
 
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Brand NameULTRAPRO MESH UNKNOWN PRODUCT
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
1000 route 202
raritan NJ 08869
Manufacturer (Section G)
ETHICON INC.-GMBH
robert-koch strasse 1
p.o. box 1409
norderstedt D2284 1
GM D22841
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
MDR Report Key12155632
MDR Text Key265154220
Report Number2210968-2021-06242
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K033337
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Reporter Occupation
Type of Report Initial
Report Date 06/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/16/2021
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?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/12/2021 Patient Sequence Number: 1
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