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

Catalog Number 0117011

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Reaction (2414); Obstruction/Occlusion (2422); Ambulation Difficulties (2544)

Event Date 03/20/2020

Event Type  Injury  

Manufacturer Narrative

As reported, it was alleged that the patient experienced bowel obstruction, inflammation, joint pain, ambulation difficulties and surgical intervention post implant of the bard soft mesh.Based on the information provided to date, no conclusion can be made as to the degree to which the bard device, may be causing or contributing the patient¿s reported symptoms.The instructions-for-use supplied with the device lists inflammation and pain as possible complications.A review of the manufacturing records was performed and found that the lot was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in october, 2018.Should additional information be provided, a supplemental mdr will be submitted.Remains implanted.

Event Description

The following was reported to bdi/davol: on (b)(6) 2020: a (b)(6)-year old male patient underwent ventral umbilical hernia repair procedure with implant of a bard/davol soft mesh.On (b)(6) 2020: the patient returned to the hospital due to a bowel obstruction and underwent additional surgical intervention.Although there was no hernia recurrence, a non-bard/davol resorbable mesh was placed on top of the previously placed bard/davol soft mesh for reinforcement of the repair and to relieve the bowel obstruction.Following the surgeries with implant of both meshes, the patient has experienced joint pain, starting at the ankles and eventually radiating to the upper extremities, inflammation, nausea, extreme fatigue, erythema at the hernia repair site, itching and ambulation difficulties.The patient was treated with two rounds of prednisone and is currently on allopurinol which was prescribed by the rheumatologist.The patient underwent multiple tests, which showed no hernia recurrence or fluid accumulations.It was reported that the patient has not had relief of the symptoms with the treatment received, can "barely walk" and is seeking treatment with a specialist.

• 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
• 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: 10809304
• MDR Text Key: 215306502
• Report Number: 1213643-2020-20036
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741030888
• UDI-Public: (01)00801741030888
• 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: consumer,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2023
• Device Catalogue Number: 0117011
• Device Lot Number: HUCW1490
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2018
• 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
• Patient Age: 51 YR