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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACUMED, LLC PLATE, FIXATION, BONE

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ACUMED, LLC PLATE, FIXATION, BONE Back to Search Results
Device Problem Migration (4003)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
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Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
ACUMED, LLC
5885 ne cornelius pass road
hillsboro OR 97124
Manufacturer (Section G)
ACUMED LLC
5885 ne cornelius pass road
hillsboro OR 97124
Manufacturer Contact
ellie wood
5885 ne cornelius pass road
hillsboro, OR 97124
5035209618
MDR Report Key14802405
Report Number3025141-2022-00201
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 06/21/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/24/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Date Manufacturer Received06/07/2022
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? No
Type of Device Usage Initial

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