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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK LLC US UNK - FLUID MANAGEMENT DISTENSION UNIT, FLUID, ARTHROSCOPIC

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DEPUY MITEK LLC US UNK - FLUID MANAGEMENT DISTENSION UNIT, FLUID, ARTHROSCOPIC Back to Search Results
Catalog Number UNK - FLUID MANAGEMENT
Device Problem Increase in Pressure (1491)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/06/2021
Event Type  malfunction  
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. This report is for an unknown fluid management device. Part and lot number are unknown. Without the specific part number; the udi number, 510-k number and manufacturing site name are unknown. Complainant part is not expected to be returned for manufacturer review/investigation. Without a lot number the device history records review could not be completed. Product was not returned. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. To date the device has not been returned. If the device or further details are received at a later date a supplemental medwatch will be sent.
 
Event Description
It was reported by the affiliate in (b)(6) that during an unknown surgery on (b)(6) 2021, it was observed that an unknown fluid management device had a pressure issue that it throttled and no alert was detected by the sensor and had a high pressure in the solution in exit while in use with an unknown fluid management device. There were no adverse patient consequences nor surgical delay reported. No additional information was provided.
 
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Brand NameUNK - FLUID MANAGEMENT
Type of DeviceDISTENSION UNIT, FLUID, ARTHROSCOPIC
Manufacturer (Section D)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6103142063
MDR Report Key12962381
MDR Text Key286648203
Report Number1221934-2021-03645
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeIT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/26/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK - FLUID MANAGEMENT
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received02/10/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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