MAUDE Adverse Event Report: CHEMENCE MEDICAL, INC. EXOFIN FUSION; CUTANEOUS TISSUE ADHESIVE WITH MESH

Catalog Number EF70401

Device Problem Material Fragmentation (1261)

Patient Problem Sepsis (2067)

Event Type  Injury  

Manufacturer Narrative

The manufacturer continues to seek information from the health care facility.At the time of this report there has been no response for requests regarding the lot number of the device, the circumstances surrounding the event, patient demographic information, or any other details that might assist in the investigation.Should additional information be received a follow-up report will be submitted.

Event Description

It was reported that a patient developed "septic total knee requiring irrigation and debridement".The patient had been treated using exofin fusion following surgery.

• Brand Name: EXOFIN FUSION
• Type of Device: CUTANEOUS TISSUE ADHESIVE WITH MESH
• Manufacturer (Section D): CHEMENCE MEDICAL, INC.; 200 technology drive; alpharetta GA 30005
• Manufacturer (Section G): CHEMENCE MEDICAL, INC.; 200 technology drive; alpharetta GA 30005
• Manufacturer Contact: daniel hoefer ; 200 technology drive; alpharetta, GA 30005 ; 6786890760
• MDR Report Key: 7978808
• MDR Text Key: 124136894
• Report Number: 3010034760-2018-00001
• Device Sequence Number: 1
• Product Code: OMD
• UDI-Device Identifier: 00854137001238
• UDI-Public: 00854137001238
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: EF70401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention