MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 MODIFIED ONFLEX; SURGICAL MESH

Catalog Number 0115610

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Urticaria (2278)

Event Date 07/02/2021

Event Type  Injury  

Manufacturer Narrative

As reported, the patient developed an allergic reaction and urticaria post-implant of the bard/davol modified onflex mesh.No product identifiers have been provided; therefore, a review of the manufacturing records is not possible.Based on the information available, no conclusions can be made.Should additional information be provided, a supplemental mdr will be submitted.

Event Description

As reported, following implant of a bard/davol modified onflex mesh, the patient experienced an allergic reaction and developed urticaria on (b)(6) 2021.As alleged, the patient was scheduled for a hospital visit on (b)(6) 2021 and the mesh is allegedly scheduled to be removed on (b)(6) 2021.

Event Description

As reported, following implant of a bard/davol modified onflex mesh, the patient experienced an allergic reaction and developed urticaria on (b)(6) 2021.As alleged, the patient was scheduled for a hospital visit on (b)(6) 2021 and the mesh is allegedly scheduled to be removed on (b)(6) 2021.Addendum: as reported, the patient underwent reactivity testing.As reported, the patient was allergic to iodine, negative to the mesh and slightly allergic to the absorbable ring.It was reported that the mesh removal was scheduled on (b)(6) 2021; the surgery has been postponed (time undecided) because the patient¿s allergic reaction symptoms (urticaria, etc.) improved before the date.The patient is under observation.

Manufacturer Narrative

As reported, the patient developed an allergic reaction and urticaria post-implant of the bard/davol modified onflex mesh.No product identifiers have been provided; therefore, a review of the manufacturing records is not possible.Based on the information available, no conclusions can be made.Addendum to the initial mdr submitted.Additional information provided states that the patient underwent reactivity testing, and was found to be allergic to iodine, and slightly allergic to the absorbable ring component within the mesh implant.As reported, the patient had no reaction to the mesh component of the implant.As reported, the patient has been under observation and their symptoms have been improving, therefore the initially scheduled explant procedure has not been undertaken.Based on the additional information received, the cause of the patient¿s complication appears to be related to a reaction to iodine and the implant¿s absorbable ring.Regarding the patient¿s reaction to the implant¿s absorbable ring, the ifu supplied with the device states that the absorbable ring ¿fully degrades in vivo by means of hydrolysis and has been found to elicit an inflammatory response during absorption.¿ should additional information be provided a supplemental mdr will be submitted.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: MODIFIED ONFLEX
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 12177526
• MDR Text Key: 261828209
• Report Number: 1213643-2021-20185
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741095399
• UDI-Public: (01)00801741095399
• Combination Product (y/n): N
• PMA/PMN Number: K142706
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/28/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: 0115610
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/02/2021
• Initial Date FDA Received: 07/15/2021
• Supplement Dates Manufacturer Received: 07/27/2021
• Supplement Dates FDA Received: 08/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention