MAUDE Adverse Event Report: Davol Inc., Sub. C.R. Bard, Inc. -1213643 Modified Kugel Patch; Surgical Mesh

Catalog Number	0115808
Medical Device Problem Codes	Defective Device (2588); Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Adhesion(s) (1695); Nerve Damage (1979); Pain (1994); Scar Tissue (2060); Injury (2348); Disability (2371)
Date of Event	01/21/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made to what extent the bard/davol modified kugel (device #1) may have caused or contributed to the reported event.The cause of the patient postoperative complications cannot be determined at this time.The attorney alleges unspecified injuries; however no details have been provided.No lot number has been provided therefore a review of the manufacturing records is not possible at this time.Information is limited.Should additional information be provided a supplemental emdr will be submitted.This emdr represents the bard/davol modified kugel (device #1).An additional emdr was submitted to represent the bard/davol perfix plug (device #2).Not returned.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of an unspecified bard/davol modified kugel patch (device #1) and an unspecified bard/davol perfix plug (device #2) on (b)(6) 2012.It is also alleged by the patient's attorney that on (b)(6) 2013, patient had unspecified injuries.As reported, the patient is making a claim for an adverse patient outcome against the modified kugel patch (device #1) and the perfix plug (device #2).As reported, the attorney alleges general allegations for "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient.".
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of an unspecified bard/davol modified kugel patch(device #1) and an unspecified bard/davol perfix plug(device #2) on (b)(6) 2012.It is also alleged by the patient's attorney that on (b)(6) 2013, patient had unspecified injuries.As reported, the patient is making a claim for an adverse patient outcome against the modified kugel patch(device #1) and the perfix plug(device #2.As reported, the attorney alleges general allegations for "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient." addendum 1: attorney alleges per short form (see attached) that the patient underwent surgery for implant of unspecified bard/davol composix kugel on (b)(6) 2011, perfix plug (rt indirect inguinal) and modified kugel patch (rt inguinal) on (b)(6) 2012, modified kugel patch (lt inguinal) and perfix plug (lt inguinal) on (b)(6) 2012.As reported, the patient is making a claim for an adverse patient outcome against the perfix plug (rt indirect inguinal), modified kugel patch (rt inguinal), modified kugel patch (lt inguinal) and perfix plug (lt inguinal).It is alleged that the patient sustained unspecified injuries on (b)(6)2013.Attorney also alleges general allegations for "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient.¿ it is also alleged that the patient experienced emotional distress and the device was defective.Addendum per additional information provided: (b)(6) 2011 - patient was diagnosed with umbilical hernia thereby underwent laparoscopic repair with implant of composix kugel (device 1).Per op notes, ¿incision was made just below the hernia sac.The hernia sac contained preperitoneal fat was reduced.The sac was excised and removed.A composix kugel (device 1) was placed and tacked.¿ (b)(6) 2012 - patient was diagnosed with right inguinal hernia thereby underwent open repair with implant of perfix plug (device 2) and modified kugel hernia patch (device 3).Per op notes, ¿transverse incision was made in right groin.The cord structures were identified and mobilized.An indirect hernia was identified and resected.A modified kugel hernia patch (device 3) was placed and sutured.A direct hernia sac was identified and resected.A perfix plug (device 2) was placed and sutured.¿ (b)(6) 2012 - patient was diagnosed with left inguinal hernia thereby underwent open repair with implant of modified kugel hernia patch (device 4) and perfix plug (device 5).Per op notes, ¿a left groin incision was made.An indirect hernia sac was identified and resected.A modified kugel hernia patch (device 4) was placed and sutured.A direct hernia sac was identified and resected.A perfix plug (device 5) was placed and sutured.¿ (b)(6) 2013 - patient was diagnosed with chronic right groin inguinodynia/pain and adhesions thereby underwent laparoscopic converted to open repair with excision of perfix plug (device 2) and modified kugel hernia patch (device 3).Per op notes, ¿on the right inguinal region, a plug (device 2) was densely adherent to the vas deferens and cord structures were taken down.Another mesh (device 3) was densely adherent to the coopers ligament were taken down.Two meshes (device 2 and 3) were freed up and excised.Extensive scarring was noted and removed.Once all the mesh was excised.Two nerves were identified and divided.The genitofemoral nerve was transected.The skin was closed with sutures.¿.
Additional Manufacturer Narrative
At this time no conclusions can be made to what extent the bard/davol modified kugel (device #1) may have caused or contributed to the reported event.The cause of the patient postoperative complications cannot be determined at this time.The attorney alleges unspecified injuries; however no details have been provided.No lot number has been provided therefore a review of the manufacturing records is not possible at this time.Information is limited.Addendum: this supplemental emdr is submitted to document additional information provided.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.Note, the manufacturing date (15-sep-2011) is considered to be a best estimate.Updated fields: a2, b2, b4, b5, b6, b7, d3, d4 (product catalog no., corporate lot.No., udi no., expiry date), d.6b (date of explant), g1, g3, g6, h2, h4, h6, h10.This supplemental emdr represents the bard/davol modified kugel patch (device #3).An additional supplemental emdr was submitted to represent the bard/davol perfix plug (device #2), bard/davol modified kugel patch (device 4) and perfix plug (device 5).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: 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 ; +1(401)825-8495
• MDR Report Key: 8426389
• Report Number: 1213643-2019-01731
• Device Sequence Number: 303541
• Product Code: FTL
• UDI-Device Identifier: 00801741030789
• UDI-Public: (01)00801741030789(17)161128(10)HUVI2060
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K963141
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2026

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 Expiration Date: 11/28/2016
• Device Catalogue Number: 0115808
• Device Lot Number: HUVI2060
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2019
• Supplement Date Received by Manufacturer: 08/12/2026
• Initial Report FDA Received Date: 03/16/2019
• Supplement Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2011
• 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; Disability
• Patient Sex: Male