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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MODO INCORPORATED UNIVERSAL CART (W/O UPS) STAND, INFUSION

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MODO INCORPORATED UNIVERSAL CART (W/O UPS) STAND, INFUSION Back to Search Results
Model Number 700-60101
Device Problems Material Deformation (2976); Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/13/2021
Event Type  malfunction  
Event Description
It was reported that the cart wheels are broken. The account reported that all four wheels to the cart are wearing due to use. This causes friction making the cart hard to push. Due to this, one wheel broke, which caused instability and resulted in the cart tipping on to a staff member. The staff member sustained minor bruising. No other injuries or complications occurred.
 
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Brand NameUNIVERSAL CART (W/O UPS)
Type of DeviceSTAND, INFUSION
Manufacturer (Section D)
MODO INCORPORATED
150 hopper avenue
waldwick NJ 07463
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
11911 n. creek parkway s.
bothell WA 98011
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key11280838
MDR Text Key231410409
Report Number2134265-2021-01160
Device Sequence Number1
Product Code FOX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 02/04/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number700-60101
Device Catalogue Number700-60101
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/14/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Reuse

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