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

Catalog Number UNKAA069

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Erythema (1840); Toxicity (2333); Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

Reactivity testing has been performed and as reported by the patient's physician there was no skin reaction to the mesh.It is unknown at this time, what is causing the patient's condition.However, based on testing performed the postoperative condition does not appear to be caused by the bard/davol mesh used to treat the patient.Remains implanted.

Event Description

It was reported that on (b)(6) 2015 the patient underwent repair of an incarcerated right side inguinal hernia with use of the bard/davol soft mesh.Of note per operative report: the soft mesh was chosen specifically for this procedure as discussed with the patient's urologist due to the patient having a penile implant with the tubing and reservoir in close proximity to the hernia.About three years later the patient developed a scaly, pruritic (itchy) rash on the inguinal hernia incision site.The patient has been treated by the dermatologist with "high potency" topical steroid cream which has lessened the symptoms but has not completely resolved the rash.The dermatologist has requested a mesh sample to perform skin patch testing on the patient.

• Brand Name: BARD SOFT MESH
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 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: laura sundberg ; 100 crossings blvd.; warwick, RI 02886 ; 4018258462
• MDR Report Key: 9648577
• MDR Text Key: 177029535
• Report Number: 1213643-2020-00749
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKAA069
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention