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

Catalog Number	0113700
Medical Device Problem Codes	Defective Device (2588); Material Deformation (2976); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/31/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided by patient's attorney: (b)(6) 2008: patient with history of small bowel obstruction was diagnosed with right inguinal hernia and underwent repair with mesh.Per operative notes, ¿the indirect sac was dissected free and a medium perfix plug (device #1) was placed and sutured.The direct sac was reduced, and a large perfix plug (device #2) was placed and sutured.The pre-shaped mesh (device #3) was then placed down and sutured¿.(b)(6) 2016: patient visited hospital due to right lower quadrant subcutaneous nodule.(b)(6) 2016: patient had pain, discomfort and was diagnosed with recurrent right direct inguinal hernia with dislodged mesh plug.The mass was extremely hard, this was mostly likely a foreign body from previous surgery.It appeared to be a plug of polypropylene mesh.Then the perfix plug (device #2) was excised and dissected away.This revealed a recurrent right direct inguinal hernia and repair was completed¿.(note: there was no mention of device #1 & #3 during the procedure).(b)(6) 2018: patient was diagnosed with infected foreign body with suture material and right upper quadrant deep muscle abscess with sinus tract.Per operative notes, ¿monofilament suture material of large caliber was revealed and released.A segment of polypropylene (device #3) which had coiled up was removed¿.(b)(6) 2018: patient was diagnosed with chronic nonhealing infected sinus tract in right upper quadrant with foreign body and suture material.(note: there was no mention of device #1 during the procedure).Attorney alleges that the patient had abscess, hernia recurrence, mesh migration, pain and emotional injuries.
Additional Manufacturer Narrative
Based on the information provided, no conclusions can be made.Per medical record review, post implant of pre-shaped mesh, patient was diagnosed with infection and underwent explant.Per op notes, ¿segment of pre-shaped mesh had coiled up".In regards to infection, the warnings section in ifu 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." this emdr represents the pre-shaped (device #3).Supplemental emdr was submitted for perfix plug (device #1) and an additional emdr was submitted to represent the perfix plug (device #2).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.
Additional Manufacturer Narrative
Based on the information provided, no conclusions can be made.Per medical record review, post implant of pre-shaped mesh, patient was diagnosed with infection and underwent explant.Per op notes, ¿segment of pre-shaped mesh had coiled up".In regards to infection, the warnings section in ifu 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." addendum: h11: this supplemental emdr is submitted to document the expiry date, manufacturing date and to correct the catalog number.Review of manufacturing records confirms product was manufactured to specification.Updated fields: d4 (expiry date, udi no.), h4 (manufacturing date).Corrected field: d4 (catalog number).This supplemental emdr represents the pre-shaped mesh (device #3).Additional supplemental emdrs were submitted to represent the perfix plugs (device #1 & device #2).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 or Problem Description
Per information provided by patient's attorney: on (b)(6) 2008: patient with history of small bowel obstruction was diagnosed with right inguinal hernia and underwent repair with mesh.Per operative notes, ¿the indirect sac was dissected free and a medium perfix plug (device #1) was placed and sutured.The direct sac was reduced, and a large perfix plug (device #2) was placed and sutured.The pre-shaped mesh (device #3) was then placed down and sutured¿.On (b)(6) 2016: patient visited hospital due to right lower quadrant subcutaneous nodule.On (b)(6) 2016: patient had pain, discomfort and was diagnosed with recurrent right direct inguinal hernia with dislodged mesh plug.The mass was extremely hard, this was mostly likely a foreign body from previous surgery.It appeared to be a plug of polypropylene mesh.Then the perfix plug (device #2) was excised and dissected away.This revealed a recurrent right direct inguinal hernia and repair was completed¿.(note: there was no mention of device #1 & #3 during the procedure).On (b)(6) 2018: patient was diagnosed with infected foreign body with suture material and right upper quadrant deep muscle abscess with sinus tract.Per operative notes, ¿monofilament suture material of large caliber was revealed and released.A segment of polypropylene (device #3) which had coiled up was removed¿.On (b)(6) 2018: patient was diagnosed with chronic nonhealing infected sinus tract in right upper quadrant with foreign body and suture material.(note: there was no mention of device #1 during the procedure).Attorney alleges that the patient had abscess, hernia recurrence, mesh migration, pain and emotional injuries.
Additional Manufacturer Narrative
Based on the information provided, no conclusions can be made.Per medical record review, post implant of pre-shaped mesh, patient was diagnosed with infection and underwent explant.Per op notes, ¿segment of pre-shaped mesh had coiled up".In regards to infection, the warnings section in ifu 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." addendum#1: h11: this supplemental emdr is submitted to document the expiry date, manufacturing date and to correct the catalog number.Review of manufacturing records confirms product was manufactured to specification.Addendum#2: h11: this supplemental emdr is submitted to correct the date of pathology report in relevant tests and lab data field.Updated fields: b4, g3, g6, h2, h10, h11.Corrected field: b6.This supplemental emdr represents the pre-shaped mesh (device #3).Additional supplemental emdrs were submitted to represent the perfix plugs (device #1 & device #2).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 or Problem Description
Per information provided by patient's attorney: (b)(6) 2008 - patient with history of small bowel obstruction was diagnosed with right inguinal hernia and underwent repair with mesh.Per operative notes, ¿the indirect sac was dissected free and a medium perfix plug (device #1) was placed and sutured.The direct sac was reduced, and a large perfix plug (device #2) was placed and sutured.The pre-shaped mesh (device #3) was then placed down and sutured¿.(b)(6) 2016 - patient visited hospital due to right lower quadrant subcutaneous nodule.(b)(6) 2016 - patient had pain, discomfort and was diagnosed with recurrent right direct inguinal hernia with dislodged mesh plug.Per operative notes, ¿the mass was extremely hard, this was mostly likely a foreign body from previous surgery.It appeared to be a plug of polypropylene mesh.Then the perfix plug (device #2) was excised and dissected away.This revealed a recurrent right direct inguinal hernia and repair was completed¿.(note: there was no mention of device #1 & #3 during the procedure).(b)(6) 2018 - patient was diagnosed with infected foreign body with suture material and right upper quadrant deep muscle abscess with sinus tract.Per operative notes, ¿monofilament suture material of large caliber was revealed and released.A segment of polypropylene (device #3) which had coiled up was removed¿.(b)(6) 2018 - patient was diagnosed with chronic nonhealing infected sinus tract in right upper quadrant with foreign body and suture material.(note: there was no mention of device #1 during the procedure).Attorney alleges that the patient had abscess, hernia recurrence, mesh migration, pain and emotional injuries.

• Brand Name: BARD MESH PRE-SHAPED
• 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: 17380648
• Report Number: 1213643-2023-092972
• Device Sequence Number: 17663278
• Product Code: FTL
• UDI-Device Identifier: 00801741030697
• UDI-Public: (01)00801741030697
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/08/2023

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 Expiration Date: 11/28/2010
• Device Catalogue Number: 0113700
• Device Lot Number: 43KPD536
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/29/2023
• Supplement Date Received by Manufacturer: 07/24/2023; 08/02/2023
• Initial Report FDA Received Date: 07/24/2023
• Supplement Report FDA Received Date: 08/01/2023; 08/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2005
• 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: 67 YR
• Patient Sex: Male
• Patient Weight: 74 KG