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

Catalog Number 0117016

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Abdominal Pain (1685); Hypersensitivity/Allergic reaction (1907); Rash (2033)

Event Date 04/15/2021

Event Type  Injury  

Manufacturer Narrative

As reported, post-implant of the bard soft mesh, the patient experienced allergic reaction, rashes and abdominal pain.As reported, a patch test performed about 4 months ago was assessed as negative.Based on the information provided, no conclusion can be made.The adverse reactions section of the instructions-for-use supplied with the device lists pain as a possible complication.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Note, the date of event is provided as a best estimate ((b)(6) 2021) based on the patch test.Should additional information be provided, a supplemental mdr will be submitted.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 Description

Hold for ce 9/1/21 the following was reported: (b)(6) 2019 - during a robotic retrorectus umbilical and epigastric hernia repair procedure, the patient was implanted with a bard soft mesh.(b)(6) 2021 - the patient underwent a patch test which showed only mild erythema and was assessed as a negative result per the allergist.(b)(6) 2021 - the patient presented to the clinic with complaints of intermittent rashes all over the body and abdominal pain.There is no recurrent hernia or any inflammation around the mesh on the ct.As reported, the symptoms occur as large welts appearing intermittently (about 3-4 days) on different parts of the body.It is also reported that the abdominal pain increases in intensity when bending at the waist or eating.As reported, the patient is taking pain medication and an otc cream for the rash.

Event Description

The following was reported: (b)(6) 2019 - during a robotic retrorectus umbilical and epigastric hernia repair procedure, the patient was implanted with a bard soft mesh.(b)(6) 2021 - the patient underwent a patch test which showed only mild erythema and was assessed as a negative result per the allergist.(b)(6) 2021 - the patient presented to the clinic with complaints of intermittent rashes all over the body and abdominal pain.There is no recurrent hernia or any inflammation around the mesh on the ct.As reported, the symptoms occur as large welts appearing intermittently (about 3-4 days) on different parts of the body.It is also reported that the abdominal pain increases in intensity when bending at the waist or eating.As reported, the patient is taking pain medication and an otc cream for the rash.

Manufacturer Narrative

As reported, post-implant of the bard soft mesh, the patient experienced allergic reaction, rashes and abdominal pain.As reported, a patch test performed about 4 months ago was assessed as negative.Based on the information provided, no conclusion can be made.The adverse reactions section of the instructions-for-use supplied with the device lists pain as a possible complication.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Note, the date of event is provided as a best estimate (15-apr-2021) based on the patch test.Addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to report the additional information (product cat #.Lot #.) received.Review of manufacturing records confirms product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in february, 2019.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.Not returned - remains implanted.

Manufacturer Narrative

As reported, post-implant of the bard soft mesh, the patient experienced allergic reaction, rashes and abdominal pain.As reported, a patch test performed about 4 months ago was assessed as negative.Based on the information provided, no conclusion can be made.The adverse reactions section of the instructions-for-use supplied with the device lists pain as a possible complication.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Note, the date of event is provided as a best estimate ((b)(6) 2021) based on the patch test.Addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to report the additional information (product cat #.Lot #.) received.Review of manufacturing records confirms product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in february, 2019.Addendum: this is an addendum to the previously submitted mdrs to document reactivity test results.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 rash.However, based on testing performed the postoperative condition of allergic reaction does not appear to be caused by the bard/davol mesh used to treat the patient.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.

Event Description

The following was reported: (b)(6) 2019 - during a robotic retrorectus umbilical and epigastric hernia repair procedure, the patient was implanted with a bard soft mesh.(b)(6) 2021 - the patient underwent a patch test which showed only mild erythema and was assessed as a negative result per the allergist.(b)(6) 2021 - the patient presented to the clinic with complaints of intermittent rashes all over the body and abdominal pain.There is no recurrent hernia or any inflammation around the mesh on the ct.As reported, the symptoms occur as large welts appearing intermittently (about 3-4 days) on different parts of the body.It is also reported that the abdominal pain increases in intensity when bending at the waist or eating.As reported, the patient is taking pain medication and an otc cream for the rash.Addendum: patient had a follow-up visit on (b)(6) 2021 with the allergist to read the results of the skin patch test.As reported, per the allergist, the patient had a negative result.

• Brand Name: BARD SOFT MESH
• 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: 12396328
• MDR Text Key: 269567978
• Report Number: 1213643-2021-20291
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K052155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 10/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2024
• Device Catalogue Number: 0117016
• Device Lot Number: HUDN2082
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR