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

Catalog Number	0115808
Medical Device Problem Codes	Defective Device (2588); Material Deformation (2976); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Abdominal Pain (1685); Pain (1994); Injury (2348); Disability (2371)
Date of Event	06/28/2010
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Currently, it is unknown to what extent the device may have caused or contributed to the reported event.The information provided alleges that the patient "was found to have exposed mesh that had come apart" and underwent an open mesh removal procedure; however, medical records are not available at this time and no sample has been returned for evaluation.No lot number has been provided; therefore a review of the manufacturing records is not possible at this time.Based on the limited information provided at this time, no conclusions can be made.Should additional information be provided a supplemental emdr will be submitted.The information provided by bard 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 bard.Not returned.
Event or Problem Description
The following was alleged by the patient's attorney: on (b)(6) 2010: the patient underwent open left inguinal hernia repair.The patient's hernia was repaired with a bard/davol small circle l7.5cm modified kugel patch, product code 0115808.On (b)(6) 2010: the patient presented to the hospital with complaints of left groin pain and was found to have exposed mesh that had come apart and underwent an open mesh removal procedure.As alleged the patient was seriously and permanently injured and has suffered and will continue to suffer physical pain due to the alleged defective kugel patch.
Event or Problem Description
The following was alleged by the patient's attorney: (b)(6) 2010: the patient underwent open left inguinal hernia repair.The patient's hernia was repaired with a bard/davol small circle l7.5cm modified kugel patch, product code 0115808.(b)(6) 2010: the patient presented to the hospital with complaints of left groin pain and was found to have exposed mesh that had come apart and underwent an open mesh removal procedure.As alleged the patient was seriously and permanently injured and has suffered and will continue to suffer physical pain due to the alleged defective kugel patch.Addendum per additional information provided: (b)(6) 2010 - patient was diagnosed with left inguinal hernia thereby underwent open repair with the implant of modified kugel patch on (b)(6) 2010.Per operative notes, ¿the hernia sac was identified and circumferentially dissected off medial to epigastric vessels.Cooper's ligament was cleared of fat.The modified kugel hernia patch mesh was used for repair.The circular preperitoneal portion was placed into the preperitoneal space and tacked to copper's ligament with sutures.¿ (b)(6) 2010 - patient was diagnosed with left groin pain.(b)(6) 2010 - patient underwent left inguinal exploration with removal of outer layer of modified kugel patch and division of genitofemoral nerve.Per operative notes, ¿the mesh found lateral to the external oblique fascia was bluntly dissected of superiorly and inferiorly and separated.A nerve-like structure found in the lateral portion of the mesh was divided and then removed.The medial portion of the mesh separated from the pubis.All of the mesh was removed.¿ attorney alleged that the patient had nerve damage and pain.It is also alleged that the patient had foreign body giant cell reaction, chronic groin pain and discomfort thereby underwent pain management.
Additional Manufacturer Narrative
Currently, it is unknown to what extent the device may have caused or contributed to the reported event.The information provided alleges that the patient "was found to have exposed mesh that had come apart" and underwent an open mesh removal procedure; however, medical records are not available at this time and no sample has been returned for evaluation.No lot number has been provided; therefore a review of the manufacturing records is not possible at this time.Based on the limited information provided at this time, no conclusions can be made.Addendum: this supplemental emdr is submitted to document additional information provided.Based on the additional information received, there is no change to initial determination, no conclusions can be made.Per medical records review, about 5 months post implant of modified kugel patch, patient was diagnosed with abdominal pain thereby underwent repair with mesh removal.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.; 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 ; 4018258495
• MDR Report Key: 7278396
• Report Number: 1213643-2018-00314
• Device Sequence Number: 14028705
• Product Code: FTL
• UDI-Device Identifier: 00801741030789
• UDI-Public: (01)00801741030789
• 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: 2010
• Device Explanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2024

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): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2018
• Supplement Date Received by Manufacturer: 09/09/2024
• Initial Report FDA Received Date: 02/16/2018
• Supplement Report FDA Received Date: 09/17/2024
• 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: Disability; Required Intervention
• Patient Age: 34 YR
• Patient Sex: Male
• Patient Weight: 76 KG