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

Catalog Number	0123680
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Inflammation (1932); Reaction (2414)
Date of Event	10/16/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 10790422
• Report Number: 1213643-2020-20031
• Device Sequence Number: 11722734
• Product Code: FTL
• UDI-Device Identifier: 00801741031199
• UDI-Public: (01)00801741031199
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K002684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/19/2020

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
• Operator of Device: Health Professional
• Device Catalogue Number: 0123680
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/16/2020
• Initial Report FDA Received Date: 11/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention