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

Catalog Number	0010102
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Adhesion(s) (1695)
Date of Event	02/20/2011
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: on (b)(6) 2005 ¿ patient was diagnosed with upper midline large ventral incisional hernia thereby underwent open repair with implant of kugel patch (device 1 and device 2).Per operative notes, ¿the old incision was reopened.There were two large defects up near the xiphoid and down towards the umbilicus.A two large kugel patches (device 1 and device 2) were placed in a horizontal manner and overlapped just very slightly.At the point of overlap, they were sutured together.¿ on (b)(6) 2011 ¿ patient was diagnosed with paraesophageal hernia thereby underwent open repair with implant of synthetic mesh.Per operative notes, ¿the hernia had been completely reduced.A large piece of mesh (device 1 and device 2) throughout the entirety of incision was identified.Patient did have a large amount of omentum protecting bowel below the mesh.Adhesions were lysed just get into the abdomen.Gastroscopy was done and the ge junction was identified intraabdominally.Partially took down the wrap, but in doing so developed a small gastrotomy in the lateral portion of the fundus involved in wrap.This was a pinhole, and bile was draining out of it.The entire paraesophageal hernia was reduced.The cruroplasty was done.The cruroplasty was then bolstered with a piece of synthetic mesh was placed and sutured to the retroperitoneum and crura around the perimeter of the mesh posterior to the esophagus.¿.
Additional Manufacturer Narrative
Root cause is inconclusive; no conclusion can be made as to the extent to which the implant may have caused or contributed to the patient's postoperative course.This mdr represents the kugel patch (device 2).An additional supplemental emdr was submitted to represent the kugel patch (device 1).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: 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: 24006482
• Report Number: 1213643-2026-00009
• Device Sequence Number: 9405718
• Product Code: FTL
• UDI-Device Identifier: 00801741016349
• UDI-Public: (01)00801741016349(10)43GOD185
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K963141
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/07/2026

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: 0010102
• Device Lot Number: 43GOD185
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 47 YR
• Patient Sex: Female