MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 3DMAX LIGHT; SURGICAL MESH

Catalog Number	0117322
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Itching Sensation (1943); Rash (2033); Hot Flashes/Flushes (2153)
Date of Event	02/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, patient underwent a robotic assisted right inguinal hernia repair with implant of a 3dmax light xl mesh on (b)(6) 2023.As reported, 2 weeks later patient developed systemic itching followed by radiating heat.About 4 days later patient developed a rash all over her abdomen, legs and arms.It was reported that the patient underwent reactivity test for mesh from (b)(6) 2023 to (b)(6) 2023.The results were negative for any reaction to the 3dmax light mesh.
Additional Manufacturer Narrative
As reported, patient experienced itching sensation followed by radiating heat and rashes.Reactivity testing has been performed and as reported the results were negative for an allergic response to the mesh sample.It is unknown at this time, what is causing the patient's condition.However, based on testing performed the postoperative conditions experienced by the patient do not appear to be caused by the 3dmax light mesh used to treat the patient.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of 181 units released for distribution in jul, 2022.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: 3DMAX LIGHT
• 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: 17009842
• Report Number: 1213643-2023-00213
• Device Sequence Number: 7493188
• Product Code: FTL
• UDI-Device Identifier: 00801741031076
• UDI-Public: (01)00801741031076
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K091659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/10/2023

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 Catalogue Number: 0117322
• Device Lot Number: HUGT0637
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/04/2023
• Initial Report FDA Received Date: 05/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2022
• 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: 63 YR
• Patient Sex: Female