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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Foreign Body Reaction (1868); Fluid Discharge (2686); Peripheral Edema (4578)
Event Date 09/04/2021
Event Type  Injury  
Event Description
It was reported that a patient underwent a tension-free herniorrhaphy of sulcus hernia under spinal anesthesia on (b)(6) 2021 and the mesh was implanted. It was reported that ten days after the surgery, the patient experienced wound secretion. Considering the rejection of the patch, right scrotal edema removal was performed. Additional information was requested.
 
Manufacturer Narrative
Product complaint # (b)(4). Device not returned. A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified. 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: weight, bmi at the time of index procedure what are the patient comorbidities/concomitant medications? was any deficiency or anomaly of the mesh? if yes, please describe it. Does the patient have known allergic history to medical device, food or medications? was the device removed? if so, please date and details of the re-operation. What is physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? how was the mesh fixated?.
 
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Brand NamePROLENE MESH 15X15CM
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
1000 route 202
raritan NJ 08869
Manufacturer (Section G)
ETHICON INC.-SAN LORENZO PR
982 road 183 km 8.3
san lorenzo 00754
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
MDR Report Key13005105
MDR Text Key286432344
Report Number2210968-2021-12599
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K962530
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberPMM3
Device Lot NumberPPBDKM
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received01/11/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/16/2019
Is the Device Single Use? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/14/2021 Patient Sequence Number: 1
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