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

Catalog Number 0117015

Device Problems No Apparent Adverse Event (3189); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Swelling (2091); Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

No conclusion can be made. Based on the information provided we are unable to determine a correlation between the patient's reported postoperative symptoms and the davol mesh product used to treat the patient. A mesh sample has been provided to the patient's allergist for reactivity testing. At this time, the testing has not been completed. A review of the manufacturing records was performed and found that the lot was manufactured to specification. Should additional information be obtained, a supplemental emdr will be submitted. The patient underwent bilateral repair, this file will represent the left side, an additional emdr (1213643-2018-03047) was submitted to represent the right side. The information provided by bard 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 bard. Remains implanted.

Event Description

As reported on (b)(6) 2018, the patient underwent the repair of bilateral inguinal hernias. The hernias were repaired with bard/davol soft mesh (lot # hubx1610). It is reported that shortly afterwards, the patient developed irritation and local pain with intermittent swelling at the surgical sites. He also has developed over recent months multiple symptoms including increased fatigue, weight loss, and ¿allergies¿ to some foods including raw apples and potatoes and to multiple medications. At this time the allergist is not certain what is causing these symptoms and would like to obtain a sample of the mesh to rule this out.

• 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: 7863998
• MDR Text Key: 119806325
• Report Number: 1213643-2018-03091
• 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

• Type of Report: Initial,Followup
• Report Date: 10/11/2018

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 09/11/2018
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: HEALTH PROFESSIONAL
• Device Catalogue Number: 0117015
• Device LOT Number: HUBX1610
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/03/2018
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 12/13/2017
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient TREATMENT DATA

Date Received: 09/11/2018 Patient Sequence Number: 1