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

Catalog Number	0123680
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information available, no conclusion can be made.As reported, the patient was implanted with a composix e/x mesh and is currently hospitalized.Additional information has been requested regarding event details and it was reported that no additional information could be provided at this time.Based on the limited information provided, we are unable to determine a root cause of the event.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Note the date of implant is estimated based on the information received, as a specific date was not provided.Should additional information be provided a supplemental emdr will be submitted.Remains implanted.
Event or Problem Description
It was reported that the patient underwent implant of a composix e/x mesh in 2005 and is currently hospitalized.As reported, the doctor inquired regarding the material content of the surgical mesh and wanted to know whether if it was "gore-tex".

• Brand Name: COMPOSIX MESH E/X
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 10052888
• Report Number: 1213643-2020-04741
• Device Sequence Number: 2834957
• Product Code: FTL
• UDI-Device Identifier: 00801741031199
• UDI-Public: (01)00801741031199
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K002684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/13/2020

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 Expiration Date: 07/28/2008
• Device Catalogue Number: 0123680
• Device Lot Number: 43GND172
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2020
• Initial Report FDA Received Date: 05/13/2020
• 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: Hospitalization