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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. MALLA PROLENE 15CM X 15CM MESH, SURGICAL, POLYMERIC

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ETHICON INC. MALLA PROLENE 15CM X 15CM MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number PMM1
Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Patient Problems Pain (1994); Fluid Discharge (2686); Not Applicable (3189)
Event Date 06/16/2020
Event Type  Injury  
Manufacturer Narrative

Product complaint # (b)(4). (b)(4). Retain sample: all the 3 retain samples were opened and physically inspected. All the three mesh packages were checked for seal condition attribute and found to be in complete sealed condition from all sides. As a part of investigation batch manufacturing record was reviewed. The batch manufacturing record was reviewed for any process deviation, but no deviation was observed. The forming pressure and temperature was also found satisfactory. The ipqa test performed at each stage is found to be satisfactory and meeting the specified requirements. While reviewing in-process quality data, package integrity test at the time of release of the product was reviewed and found to be satisfactory & meet the specifications. Package integrity test will directly impact sterility of the suture. Hence this report was reviewed. The sterilization run report was reviewed and found to meet the specification. All the sterilization parameters were observed to be within limits as specified in the process specifications. Finished good test record was reviewed and found to meet the specification. No deviations or abnormalities were reported during testing and monitoring of the incident lot. From the above analysis it is evident that there was no issue related to the sterilization, sterility, quality and processing of this incident lot. The above analysis and device history record review shows that there was no issue related to processing of the lot. From review of sterilization records, it can be concluded that the product was sterile. The condition under which the sterility test was performed was also found to meet the aseptic requirements of classified area. This review indicated that there were no quality concerns associated with the manufacturing process & sterilization process and the device is not likely related to the event. 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 were current symptoms following the index surgical procedure? onset date? what are the patient comorbidities/concomitant medications? were any concomitant procedures performed? onset date/time of the pain from surgery location and character of the pain? is there any specific activity that precipitated the pain or eased the pain? what medical intervention was given for the pain management? results? if reoperation was performed please provide date and surgical findings was the device removed? if so, please date and details of the re-operation. Please confirm product code and lot # as pmm101 lot v9008 is for a suture product what is physician¿s opinion as to the etiology of or contributing factors to this event what is the patient's current status? if applicable, will product be returned, return date, tracking information.

 
Event Description

It was reported that a patient underwent a ventral hernia/emergency laparotomy surgery in (b)(6) 2020 and the prolene 15x15 mesh was implanted. It was reported that post surgery, day 7 onward, there was a persistence of watery discharge/ serous discharge coming from the wound. It was reported that there is no abscess. It was also reported that the patient is having abdominal pain. It was also reported that other medical intervention was required and the patient required revision surgery. It was also reported that other medical intervention was required.

 
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Brand NameMALLA PROLENE 15CM X 15CM
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876
Manufacturer (Section G)
ETHICON INC - AURANGABAD
312379@b-15/1
1 waluj
aurangabad 43113 3
IN 431133
Manufacturer Contact
elba bello
p.o. box 151, route 22 west
somerville, NJ 08876
9082183429
MDR Report Key10524721
MDR Text Key209969348
Report Number2210968-2020-06815
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeIN
PMA/PMN NumberK962530
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/12/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/11/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberPMM1
Device LOT NumberV9008
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 Received10/02/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/01/2019
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: 09/11/2020 Patient Sequence Number: 1
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