MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 SEPRAMESH IP; SURGICAL MESH

Catalog Number	5959812
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Sepsis (2067); Septic Shock (2068); Thromboembolism (2654)
Date of Event	10/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the patient underwent an incisional hernia repair and was implanted with a sepramesh ip on (b)(6) 2023.The patient did well and was discharged eighteen (18) hours after the procedure.As reported a few hours after discharge, the patient returned in septic shock and was diagnosed with pte (pulmonary thromboembolism) and developed sepsis.The surgeon emphasized that he is not attributing the complication to the mesh, but that he is raising all possibilities because they have not identified the possible cause of the complication.
Additional Manufacturer Narrative
As reported, post implant of the sepramesh ip the patient presented with septic shock, pte, and sepsis thereby hospitalized.Surgeon does not know the cause of the patient¿s symptoms but rather, seeing all the possibilities for the patient's reaction.Based on the information provided, no conclusions can be made.Review of manufacturing/sterilization records confirms product was manufactured to specification, with no anomalies noted.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in july 2022.Note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• Brand Name: SEPRAMESH IP
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 18049613
• Report Number: 1213643-2023-00400
• Device Sequence Number: 12825525
• Product Code: FTL
• UDI-Device Identifier: 00801741031830
• UDI-Public: (01)00801741031830
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K063739
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/17/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/28/2024
• Device Catalogue Number: 5959812
• Device Lot Number: HUGS1012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2023
• Initial Report FDA Received Date: 11/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening
• Patient Sex: Male