MAUDE Adverse Event Report: ETHICON INC. PROCEED VENTRAL PATCH UNKNOWN PRODUCT; MESH, SURGICAL, POLYMERIC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fever (1858); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Pain (1994); Seroma (2069); Hernia (2240); Impaired Healing (2378); Obstruction/Occlusion (2422); Unspecified Tissue Injury (4559)

Event Type  Injury  

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.This report is related to a clinical evaluation report; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.(b)(4).The single complaint was reported with multiple events.There are no additional details regarding the additional events.

Event Description

This report is being filed after the review of a clinical evaluation report (cer) from a related research activity database (drra) for patients undergoing unknown procedure.The reported complication as per icd 9 & 10 categorization experienced by the following with corresponding intervention: open umbilical hernia repair (5-years follow-up) perioperative and 5-year follow-up outcomes.Intraoperative complications - total 3 - bleeding - 2, organ injuries - 1, vascular - 0, bowel - 1, bladder - 0, stomach - 0, spleen - 0, liver - 0, others - 0.General complications - total 12 - fever 1, urinary tract infection 0, diarrhea 0, gastritis 0, thrombosis 0, pulmonary embolism 0, pleural effusion 0, pneumonia 0, copd 1, cardiac insufficiency 0, coronary hearth disease 1, myocardial infarction 0, renal insufficiency 0, hypertensive crisis 1, patient deceased 0, others 10.Postoperative complications - total 48 - bleeding 13, seroma 15, prolonged ileus or obstruction 1, bowel injury/anastomotic insufficiency 0, wound healing disorder 14, infection 12.Complication-related reoperations - total 8 recurrence, pain and complications on 5-year follow-up - recurrence - 53, pain on exertion - 45, pain at rest - 17, pain requiring treatment - 11, trocar hernia - 2, secondary hemorrhage - 5, seroma - 12, infection - 21.

• Brand Name: PROCEED VENTRAL PATCH UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-GMBH; robert-koch strasse 1; norderstedt ; GM
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16055850
• MDR Text Key: 306239662
• Report Number: 2210968-2022-10673
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K061533
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/08/2022
• Initial Date FDA Received: 12/27/2022
• 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?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention