MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 MODIFIED KUGEL PATCH; SURGICAL MESH

Catalog Number	0115808
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Abscess (1690); Unspecified Infection (1930)
Date of Event	04/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information available, no conclusions can be made.The information provided is limited to the journal article.Based on information obtain in the article it appears the abscess / mesh infection was a result of cascading events that started with a fistula due to sigmoid colon diverticulitis, and subsequent colon resection with colostomy.There is no information found in the article to indicate a mesh related cause for the patient¿s clinical course.However, regarding infection, the warnings section of the instructions-for-use, provided with the device states: " if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the mesh.An unresolved infection may require removal of the device." no lot number has been provided; therefore, a review of the manufacturing records is not possible.Note, the date of event and the date of implant are estimated based on the information provided.Note, we were unable to locate an english translation of the attached article/abstract.
Event or Problem Description
Per journal article: hernia week 2022 yokohama: abstracts of scientific meetings of the japanese hernia society, vol.20: inguinal hernia mesh infection after colostomy.In (b)(6) 2017, the patient underwent repair of a right inguinal hernia via an anterior approach, with the implant of a modified kugel mesh.In (b)(6) 2019, the patient experienced a vesico constrictor fistula due to sigmoid colon diverticulitis.In (b)(6) 2019, the patient underwent laparoscopic sigmoid colon resection and ileal colostomy.In early (b)(6) 2020, swelling and pain were observed in the right inguinal region, and a ct scan revealed a subcutaneous abscess and abscess formation around the mesh, which led to hospitalization.After admission, a catheter was inserted and drained from the subcutaneous and mesh abscesses, respectively, and the abscess cavity was reduced, and both symptoms and blood sampling improved.The cause of the mesh infection was the presence of a colostomy near the upper edge of the mesh, and infection from the colostomy was considered a possible cause of the mesh infection.One week after drainage, ileal colostomy was performed.After the colostomy was closed, we confirmed that the abscess cavity had shrunk further, and the catheter was removed.The patient was discharged from the hospital about one month after admission without any problems.One year, nine months later there has been no recurrence of the issue.Although removal of the mesh is generally required for treatment of mesh infection, it was reported here a case in which a mesh infection occurred but improved without removal of the mesh.

• Brand Name: MODIFIED KUGEL PATCH
• 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: 16396698
• Report Number: 1213643-2023-00054
• Device Sequence Number: 17564117
• Product Code: FTL
• UDI-Device Identifier: 00801741030789
• UDI-Public: (01)00801741030789
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K963141
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Literature
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/07/2023

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 Catalogue Number: 0115808
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/30/2023
• Initial Report FDA Received Date: 02/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male