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

Catalog Number	0116321
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Itching Sensation (1943); Rash (2033); Swelling/ Edema (4577)
Date of Event	03/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, during a robotic bilateral inguinal hernia repair on (b)(6) 2023, patient was implanted with 3dmax mid mesh right groin (device #1) and 3dmax mid mesh left groin (device #2).It was reported that the patient developed symptoms of itching and rash of bilateral ue and groin and facial swelling on (b)(6) 2023.It was also reported that patient was provided with the treatment including antihistamines, oral and topical corticosteroids, anti-itch.The patient underwent reactivity testing with mesh however the surgeon reports not having any results as of and immunologist is suspicious of a single dose of cipro being the inciting agent.
Additional Manufacturer Narrative
Based on the information provided, no conclusions can be made.Reactivity testing has been performed however results have not been provided.As reported the patient¿s immunologist is suspicious the reaction may have been caused by a medication.If/when reactivity test results are provided, a supplemental mdr will be submitted.The adverse reaction section of the instructions-for-use, supplied with the device identifies allergy reaction as a possible complication.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in oct, 2022.This mdr represents the 3dmax mid (device #1).An additional mdr was submitted to represent the 3dmax mid (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 - remains implanted.
Additional Manufacturer Narrative
Based on the information provided, no conclusions can be made.Reactivity testing has been performed however results have not been provided.As reported the patient¿s immunologist is suspicious the reaction may have been caused by a medication.If/when reactivity test results are provided, a supplemental mdr will be submitted.The adverse reaction section of the instructions-for-use, supplied with the device identifies allergy reaction as a possible complication.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of 514 units released for distribution in (b)(6), 2022.Addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to document the reactivity test result.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 mid mesh used to treat the patient.Updated fields: b4, b5 (event description), b6 (relevant tests and lab data), b7 (other relevant history), g3, g6, h2, h6, h10.This supplemental mdr represents the 3dmax mid (device #1).An additional supplemental mdr was submitted to represent the 3dmax mid (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 - remains implanted.
Event or Problem Description
As reported, during a robotic bilateral inguinal hernia repair on (b)(6) 2023, patient was implanted with 3dmax mid mesh right groin (device #1) and 3dmax mid mesh left groin (device #2).It was reported that the patient developed symptoms of itching and rash of bilateral ue and groin and facial swelling on (b)(6) 2023.It was also reported that patient was provided with the treatment including antihistamines, oral and topical corticosteroids, anti-itch.The patient underwent reactivity testing with mesh however the surgeon reports not having any results as of and immunologist is suspicious of a single dose of cipro being the inciting agent.Addendum: final reactivity test results showed no reaction to the 3dmax mid mesh.

• Brand Name: 3DMAX MID
• 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: 16894460
• Report Number: 1213643-2023-00183
• Device Sequence Number: 14987958
• Product Code: FTL
• UDI-Device Identifier: 00801741200786
• UDI-Public: (01)00801741200786
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K200818
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2023

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 Catalogue Number: 0116321
• Device Lot Number: HUGTAB09
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/19/2023
• Supplement Date Received by Manufacturer: 05/10/2023
• Initial Report FDA Received Date: 05/09/2023
• Supplement Report FDA Received Date: 05/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2022
• 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: 71 YR
• Patient Sex: Male