MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. VENTRALIGHT ST MESH; SURGICAL MESH

Catalog Number	5954680
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Abdominal Pain (1685); Hernia (2240); Obstruction/Occlusion (2422)
Date of Event	12/01/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, no conclusions can be made.Per the medical record review, post implant of ventralight st mesh, patient was diagnosed with hernia recurrence, bowel obstruction and abdominal pain.The adverse reaction section of the instructions-for-use, supplied with the device identify hernia recurrence as a possible complication.This emdr represents ventralight st (device #1).An additional supplemental emdr is submitted to represent ventralex st (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.
Event or Problem Description
Per information provided by the patient's attorney: (b)(6) 2014 - patient was diagnosed with incisional hernia thereby underwent open repair with the implant of ventralight st (device #1).Per operative notes, "the hernia sac was dissected down in the abdominal cavity and the sac was opened.The omental and bowel adhesions were taken down and the hernia sac was resected completely.A piece of ventralight st (device #1) was placed and sutured.¿ (b)(6) 2014 - patient visited hospital for abdominal pain.(b)(6) 2014 - patient had small recurrence at the apex more superior aspect of prior hernia repair.(b)(6) 2014 - patient was diagnosed with recurrent incisional hernia and right inguinal hernia thereby underwent open repair with the implant of ventralex st (device #2) and synthetic mesh.Per operative notes, "the hernia defect was identified and the sac was opened.A ventralex st mesh (device #2) was placed to the undersurface of the fascia and sutured.There was some weakening of inguinal floor.We then placed a piece of synthetic mesh and sutured." (note: there was no mention/visualization of device #1).(b)(6) 2015 - patient was diagnosed with slight recurrence at the midportion of incision.(b)(6) 2015 to (b)(6) 2016 - patient frequently visited hospital for abdominal pain and was diagnosed with bowel obstruction thereby underwent placement of nasogastric tube.(b)(6) 2018 to (b)(6) 2018 - patient frequently visited hospital for bilateral lower extremity pain and stomach pain.Attorney alleges that the patient had hernia recurrence, bowel obstruction, adhesions, nausea, vomiting, diarrhea, requiring revision but too dangerous to do surgery, pain and emotional injuries.

• Brand Name: VENTRALIGHT ST MESH
• 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: 18083120
• Report Number: 1213643-2023-094436
• Device Sequence Number: 7869245
• Product Code: FTL
• UDI-Device Identifier: 00801741031656
• UDI-Public: (01)00801741031656
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K101851
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/07/2023

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: 11/28/2015
• Device Catalogue Number: 5954680
• Device Lot Number: HUXK0048
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/16/2023
• Initial Report FDA Received Date: 11/07/2023
• 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: Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Weight: 56 KG