MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 VENTRALIGHT ST W/ ECHO 2; SURGICAL MESH

Catalog Number	5990011
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	High Blood Pressure/ Hypertension (1908); Pain (1994); Neuralgia (4413)
Date of Event	04/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the patient underwent a ventral hernia repair using a ventralight st mesh echo 2 ps on (b)(6) 2021.About 3 weeks post implant, the patient experienced high blood pressure, severe headaches, and pain all over.As alleged, the patient has a history of arthritis but the severity of her pain in joints increased since the implant of the ventralight st mesh.As reported, the patient complains of severe shooting pain in her tailbone that shoots up her spine and into her head.Note, the patient had recent neck surgery on (b)(6) 2023 and developed a mrsa infection which was treated aggressively with iv antibiotics.As reported, the patient has ¿many allergies and is very sensitive to multiple materials.¿ the patient did not have any visible reactions on the skin post implant, the symptoms have been all systemic and the patient is taking lortab for chronic pain.The patient underwent reactivity testing with mesh on (b)(6) 2023 for 48 hours.It was reported the patient felt unwell and experienced itching around the area where the mesh was placed but no obvious rash.Upon removal of the mesh the itching stopped.As reported the patient¿s doctor does not feel the patient had a ¿true reaction¿ to the mesh and she ¿definitely doesn¿t believe the mesh is the underlying cause of the patient¿s current health issues.¿ per patient request, the patient is being referred to a surgeon for mesh removal.
Additional Manufacturer Narrative
Based on the information provided the patient¿s doctor does not believe the patient¿s current health issues are related to the implant, and reactivity testing did not show a ¿true reaction¿ to the mesh.It is unclear at this time what is causing the patient¿s current health issues, no conclusion can be made.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of 182 units released for distribution in august 2021.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.

• Brand Name: VENTRALIGHT ST W/ ECHO 2
• 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 ; 8005566756
• MDR Report Key: 16809588
• Report Number: 1213643-2023-00158
• Device Sequence Number: 6034151
• Product Code: FTL
• UDI-Device Identifier: 00801741130977
• UDI-Public: (01)00801741130977
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K170294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/11/2023

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: 06/28/2022
• Device Catalogue Number: 5990011
• Device Lot Number: HUFU0192
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/03/2023
• Initial Report FDA Received Date: 04/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2021
• 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: 55 YR
• Patient Sex: Female