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

Catalog Number	0010105
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Fistula (1862); Pain (1994); Post Operative Wound Infection (2446)
Date of Event	07/01/2010
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the contents of the article, no conclusions can be made.The information provided is limited to the article.The journal article did not include any analysis of how or if the kugel patch potentially caused or contributed to any patient outcome or complications however concluded that transperineal repair (tpr) using a mesh with a memory-recoil ring is safe, feasible and promising technique for sph repairs.Fistula, pain, and infection are known inherent risks of surgery.The instructions-for-use supplied with the device lists fistula as a possible complication.Regarding infection, the warning section 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 (01-jul-2010) is considered to be a best estimate as based on the information available.This mdr represents patient #3 and additional six mdr's have been submitted to represents other six patients involved in the study.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.
Event or Problem Description
Per journal article, ¿transperineal repair of secondary perineal hernia using a mesh with a memory-recoil ring." the aim of this study was to evaluate the effectiveness of transperineal repair of secondary perineal hernia (sph) using a mesh with a memory-recoil ring.The article describes seven patients with secondary perineal hernia who underwent transperineal repair (tpr) between july 2010 and may 2022 were retrospectively analyzed.All sphs developed after abdominoperineal resections in patients with anorectal malignancies.The article concluded that transperineal repair (tpr) using a mesh with a memory-recoil ring is safe, feasible and promising technique for sph repairs.This mdr represents patient #3.The article describes a 78-year-old female patient with secondary perineal hernia developed after abdominoperineal resections in patient with anorectal malignancies who underwent transperineal repair (tpr) with a kugel patch.The article states there was an ¿intraoperative vaginal injury¿ which was closed with absorbable sutures.Patient experienced post operative complications of perineal wound infection, pain, and vaginal fistula.The vaginal fistula resolved with conservative treatment within 3 months.

• Brand Name: 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: 18182840
• Report Number: 1213643-2023-00446
• Device Sequence Number: 7653054
• Product Code: FTL
• UDI-Device Identifier: 00801741016370
• UDI-Public: (01)00801741016370
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K963141
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/08/2023

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: 0010105
• 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: 10/31/2023
• Initial Report FDA Received Date: 11/21/2023
• 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: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female