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

Catalog Number 0112720

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Abdominal Pain (1685); Obstruction/Occlusion (2422); Swelling/ Edema (4577)

Event Date 07/10/2020

Event Type  Injury  

Manufacturer Narrative

No conclusion can be made.As reported 3 ½ years post implant of a undefined ¿marlex mesh¿ the patient experienced obstruction, pain, and swelling.Medical records provided were limited to the implant procedure, limiting the information available.In addition, product code and lot number of the undefined implanted device have not been provided; as such, we cannot confirm bard/davol to be the manufacturer of the device in question.Additionally, without a lot number a review of the manufacturing records cannot be conducted.Note, the date of event is provided as a best estimate based on the information provided.Should additional information be provided, a supplemental mdr will be submitted.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 Description

As reported, the patient underwent the repair of a ¿strangulated hernia¿ and was implanted with a ¿marlex mesh.¿ as reported 3 ½ years post implant, the patient experienced a bowel obstruction, for which she claims is due to the defective ¿marlex mesh.¿ as alleged, the patient is experiencing severe swelling, abdominal pain and ¿electrical pain down to both legs.¿ as alleged, the patient will undergo additional surgeries.Medical records provided in follow up indicate that the patient underwent an inguinal hernia repair with placement of a "marlex" mesh.The mesh is indicated per the operative report, to have been cut to size and placed in the inguinal canal.

Manufacturer Narrative

No conclusion can be made.As reported 3 ½ years post implant of a undefined ¿marlex mesh¿ the patient experienced obstruction, pain, and swelling.Medical records provided were limited to the implant procedure, limiting the information available.In addition, product code and lot number of the undefined implanted device have not been provided; as such, we cannot confirm bard/davol to be the manufacturer of the device in question.Additionally, without a lot number a review of the manufacturing records cannot be conducted.Note, the date of event is provided as a best estimate based on the information provided.Addendum: h11: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to document that a lot number has been provided.The additional details provided does not change the initial determination, no conclusion can be made.A review of the manufacturing records was performed and found that the lot was manufactured to specification.To date, this is the only reported complaint from this manufacturing lot of (b)(4) units released for distribution in september, 2013.Should additional information be provided, a supplemental mdr will be submitted.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.H3 other text: not returned.

Event Description

As reported, the patient underwent the repair of a ¿strangulated hernia¿ and was implanted with a ¿marlex mesh.¿ as reported 3 ½ years post implant, the patient experienced a bowel obstruction, for which she claims is due to the defective ¿marlex mesh.¿ as alleged, the patient is experiencing severe swelling, abdominal pain and ¿electrical pain down to both legs.¿ as alleged, the patient will undergo additional surgeries.Medical records provided in follow up indicate that the patient underwent an inguinal hernia repair with placement of a "marlex" mesh.The mesh is indicated per the operative report, to have been cut to size and placed in the inguinal canal.

Event Description

As reported, the patient underwent the repair of a ¿strangulated hernia¿ and was implanted with a ¿marlex mesh.¿ as reported 3 ½ years post implant, the patient experienced a bowel obstruction, for which she claims is due to the defective ¿marlex mesh.¿ as alleged, the patient is experiencing severe swelling, abdominal pain and ¿electrical pain down to both legs.¿ as alleged, the patient will undergo additional surgeries.Medical records provided in follow up indicate that the patient underwent an inguinal hernia repair with placement of a "marlex" mesh.The mesh is indicated per the operative report, to have been cut to size and placed in the inguinal canal.Addendum per medical records: (b)(6) 2016 - the patient had incarcerated left inguinal hernia with repair that included implant of a bard flat mesh.Per the operative report details, "a piece of marlex mesh (bard flat mesh) was cut to an appropriate size and laid down over the floor of the inguinal canal.It was sutured to the shelving edge of the inguinal ligament inferiorly".(b)(6) 2020 - the patient was admitted to hospital and diagnosed with acute cholecystitis, small bowel obstruction, adhesion, abdominal pain.(b)(6) 2020 - the patient underwent exploratory laparotomy, small bowel resection, removal of intra-abdominal masses.

Manufacturer Narrative

No conclusion can be made.As reported 3 ½ years post implant of a undefined ¿marlex mesh¿ the patient experienced obstruction, pain, and swelling.Medical records provided were limited to the implant procedure, limiting the information available.In addition, product code and lot number of the undefined implanted device have not been provided; as such, we cannot confirm bard/davol to be the manufacturer of the device in question.Additionally, without a lot number a review of the manufacturing records cannot be conducted.Note, the date of event is provided as a best estimate based on the information provided.Addendum 1: h11: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to document that a lot number has been provided.The additional details provided does not change the initial determination, no conclusion can be made.A review of the manufacturing records was performed and found that the lot was manufactured to specification.To date, this is the only reported complaint from this manufacturing lot of 561 units released for distribution in (b)(6) 2013.Addendum 2: h11: this is an addendum to the initial and supplemental fu1 mdr submitted.The patient obstruction procedure performed in 2020 was approx.4-years after the implant of the bard mesh to treat her hernia repair.The procedure in 2020 makes no mention of the previously placed implant.As such there is no indication of a connection between the obstruction and the use of the bard mesh to treat her hernia.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.H3 other text : not returned - remains implanted.

• Brand Name: BARD FLAT MESH
• Type of Device: 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: 11562611
• MDR Text Key: 242054454
• Report Number: 1213643-2021-20059
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741016561
• UDI-Public: (01)00801741016561
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2018
• Device Catalogue Number: 0112720
• Device Lot Number: HUXH0147
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 55 KG