MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 COMPOSIX MESH E/X; SURGICAL MESH

Catalog Number 0123680

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Inflammation (1932); Reaction (2414)

Event Date 10/16/2020

Event Type  Injury  

Manufacturer Narrative

As reported, it is alleged that post-implant of the composix e/x mesh, the patient developed an aseptic inflammatory reaction.Based on the information provided, it is unclear as to the degree to which the composix e/x mesh may have caused or contributed to the patient¿s postoperative course.No lot number has been provided; therefore, a review of the manufacturing records is not possible.The instructions-for-use (ifu) supplied with the device lists inflammation as a possible complication.Should additional information be provided, a supplemental mdr will be submitted.Not returned - remains implanted.

Event Description

It was reported that the patient was implanted with a composix e/x elliptical mesh in the thoracic cavity for chest wall reconstruction.It is alleged that the patient developed a post-op aseptic inflammatory reaction on (b)(6) 2020; an allergic reaction was also one of the possibilities.

• Brand Name: COMPOSIX MESH E/X
• 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: 10790422
• MDR Text Key: 214730709
• Report Number: 1213643-2020-20031
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031199
• UDI-Public: (01)00801741031199
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K002684
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0123680
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/16/2020
• 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