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

Catalog Number 5950009

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Rash (2033); Reaction (2414)

Event Date 11/05/2020

Event Type  Injury  

Manufacturer Narrative

Based on the information provided, we are unable to determine a correlation between the patient¿s reported reaction and the bard ventralex st mesh used to treat the patient.Allergic reaction is identified in the adverse reactions section of the instructions-for-use as a possible complication.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 from this manufacturing lot of (b)(4) units released for distribution in may 2018.Should additional information be provided, a supplemental mdr will be submitted.Not returned - remains implanted.

Event Description

As reported, on (b)(6) 2018 the patient underwent an umbilical hernia repair and was implanted with a ventralex st mesh.As reported, there were no post operative complications and the patient was last seen by the implanting surgeon in (b)(6) 2019.The patient did not have any additional surgical intervention that the surgeon was aware of.As reported, the patient has rash all over the body which required long-term steroid use.

• Brand Name: VENTRALEX ST
• 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: 10874374
• MDR Text Key: 217299410
• Report Number: 1213643-2020-20051
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031496
• UDI-Public: (01)00801741031496
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101928
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/06/2020

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 Expiration Date: 04/28/2020
• Device Catalogue Number: 5950009
• Device Lot Number: HUCP2147
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/05/2020
• Initial Date FDA Received: 11/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2018
• 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): Other
• Patient Age: 61 YR