MAUDE Adverse Event Report: ETHICON INC. PROCEED*SURG MESH/MULTI LYR; MESH, SURGICAL, POLYMERIC

Model Number PCDG1

Device Problem Material Split, Cut or Torn (4008)

Patient Problems Failure of Implant (1924); Hernia (2240)

Event Date 09/16/2022

Event Type  Injury  

Event Description

It was reported that a patient underwent a hernia repair procedure on (b)(6) 2022 and the mesh was implanted.It was reported that the doctor performed the procedure on the day, (b)(6) 2022, using the mesh but had to re-approach the patient on the day, (b)(6) 2022, three days after the procedure.It was reported that according to the medical report: the patient on 3 po evolved with eventration.It was observed that the mesh remained properly fixed, however it broke in its central portion, forming a 3 cm diameter hole, allowing small bowel loops to pass through it and imprisoning them.Additional information has been requested.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc., or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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.1.The patient demographic info: age, gender, weight, bmi at the time of index procedure 2.Name of initial surgical procedure 3.The diagnosis and indication for the initial surgical procedure? 4.What were current symptoms following the index surgical procedure? onset date? 5.Other relevant patient history/concomitant medications 6.What was the defect size/type/location of the hernia associated with this event? 7.Mesh size and overlap? 8.Was the procedure associated with this event open or laparoscopic? if applicable in what tissue layer did you place the mesh? (onlay, retro-muscular, extra peritoneal or intra-abdominal) 9.If applicable, closure of the defect (yes or no), use of stay sutures (how many), permanent or absorbable? 10.If applicable, the mesh fixation technique: device and technique? (single or double crown; spacing between implants) 11.Were there any surgical instruments used in the placement of the mesh that might have damaged the mesh? e.G.Graspers crimping the mesh fibers 12.How much time from initial hernia repair to hernia recurrence? 13.Was there any triggering event prior to present recurrence? (e.G.Weight gain, sneezing, coughing, strenuous activity)? 14.How was the recurrence diagnosed? 15.What are the surgical findings of the re-operation? 16.Mesh location and integrity 17.Will any pictures be sent? 18.If applicable, will product be returned, return date, tracking information? 19.What is physician¿s opinion as to the etiology of or contributing factors to this event? 20.What is the patient's current status?.

Manufacturer Narrative

(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.H3 analysis summary: the product was returned to ethicon for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample determined that it was received one used mesh that pertains to product code pcdg1.During the visual assessment of the returned sample, it was noted a hole in the mesh and body fluids.In addition, it was observed damages due to that has begun the process of degradation in the mesh.As per the return condition of the sample no functional test could be performed.Although no conclusion could be reached on the cause of the reported event.The instructions for use do contain the following caution: correct surface orientation is critical for proceed¿ mesh to function as intended.The polypropylene mesh side (side with the blue stripes) of the product should be placed adjacent to those tissues where tissue ingrowth is desired.The other surface, the orc side, should be placed adjacent to those tissues where minimal tissue attachment is desired (i.E.Visceral surfaces).This orientation is essential.As part of ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.A manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified.

• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-CORNELIA; 655 ethicon circle; cornelia GA
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15639752
• MDR Text Key: 302090229
• Report Number: 2210968-2022-08598
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10705031047716
• UDI-Public: 10705031047716
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K060713
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: PCDG1
• Device Catalogue Number: PCDG1
• Device Lot Number: RPBBKRA0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/03/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention