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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK LLC US 4590 FMS SOLO IRRIGATION PUMP -NS DISTENSION UNIT, FLUID, ARTHROSCOPIC

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DEPUY MITEK LLC US 4590 FMS SOLO IRRIGATION PUMP -NS DISTENSION UNIT, FLUID, ARTHROSCOPIC Back to Search Results
Model Number 284590
Device Problems Increase in Pressure (1491); Overfill (2404)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It was reported by the sales rep that during an unknown surgery on an unknown date, it was observed that the pressure on the 4590 fms solo irrigation pump device was increasing and and the chamber kept filling up. Another like device was used to complete the procedure. There were no adverse patient consequences nor surgical delay reported. No additional information was provided.
 
Manufacturer Narrative
Additional narrative: udi: (b)(4). 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 sales rep that during an unknown surgery on an unknown date, it was observed that the pressure on the 4590 fms solo irrigation pump device was increasing and and the chamber kept filling up. Another like device was used to complete the procedure. There were no adverse patient consequences nor surgical delay reported. No additional information was provided.
 
Manufacturer Narrative
Additional narrative: udi: (b)(4). 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.
 
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Brand Name4590 FMS SOLO IRRIGATION PUMP -NS
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 Key12911416
MDR Text Key285168771
Report Number1221934-2021-03527
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K002040
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/17/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number284590
Device Catalogue Number284590
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Date Manufacturer Received12/28/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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