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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK LLC US IRRIGATION TUBESET 24PK SURGICAL IRRIGATION TUBING SET, GENERAL-PURPOSE

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DEPUY MITEK LLC US IRRIGATION TUBESET 24PK SURGICAL IRRIGATION TUBING SET, GENERAL-PURPOSE Back to Search Results
Catalog Number 284504
Device Problems Excess Flow or Over-Infusion (1311); Increase in Pressure (1491)
Patient Problems Swelling (2091); Not Applicable (3189)
Event Date 07/18/2019
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Udi: (b)(4), incomplete. The lot number is unknown.
 
Event Description
It was reported by the affiliate via email that the fms vue pump, which controls the pressure of the physiological solution inside the shoulder, did not correctly regulate the pressure inside the patient's shoulder, and thereby generating an inflammation in the joint capsule. While checking the fms fluid management system/inflow tubing (fms duo+ or fms solo), it was verified that it is not compatible with the connection, the correct inlet tube would be fms fluid management system inflow tubing (fms vue) for this reason it is estimated that the inflammation was generated in the patient.
 
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Brand NameIRRIGATION TUBESET 24PK
Type of DeviceSURGICAL IRRIGATION TUBING SET, GENERAL-PURPOSE
Manufacturer (Section D)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
Manufacturer (Section G)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6103142063
MDR Report Key8903330
MDR Text Key154727525
Report Number1221934-2019-58030
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeAR
PMA/PMN Number
K951843
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/19/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/16/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number284504
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/09/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/10/2019
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?
Type of Device Usage

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