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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. TOTAL HIP PACK ORTHOPEDIC TRAY

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MEDLINE INDUSTRIES, INC. TOTAL HIP PACK ORTHOPEDIC TRAY Back to Search Results
Model Number DYNJ901823
Device Problem Material Puncture/Hole (1504)
Patient Problem Insufficient Information (4580)
Event Date 05/04/2021
Event Type  Malfunction  
Event Description

Two (2) medline total hip procedure and total hip packs with compromised (holes) in the table cover upon opening of the sterile pack. The clear, outside dust cover was intact for both packs. Fda safety report id# (b)(4).

 
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Brand NameTOTAL HIP PACK
Type of DeviceORTHOPEDIC TRAY
Manufacturer (Section D)
MEDLINE INDUSTRIES, INC.
MDR Report Key11790067
MDR Text Key249749355
Report NumberMW5101230
Device Sequence Number1
Product Code OJH
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 05/05/2021
2 DeviceS WERE Involved in the Event: 1   2  
0 PatientS WERE Involved in the Event:
Date FDA Received05/06/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberDYNJ901823
Device Catalogue NumberDYNJ901823
Device LOT Number21ABL238
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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