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

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.

• Brand Name: MALLA PROLENE 15CM X 15CM
• Type of Device: MESH, 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 Key: 10524721
• MDR Text Key: 209969348
• Report Number: 2210968-2020-06815
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (Y/N): N
• Reporter Country Code: IN
• PMA/PMN Number: K962530
• Number of Events Reported: 1
• 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 Received: 09/11/2020
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: HEALTH PROFESSIONAL
• Device Catalogue Number: PMM1
• Device LOT Number: V9008
• 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 Received: 10/02/2020
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 06/01/2019
• 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