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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZHEJIANG LONGMED MEDICAL TECHNOLOGY CO., LTD. APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
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ZHEJIANG LONGMED MEDICAL TECHNOLOGY CO., LTD. APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED Back to Search Results
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Event Description
The complaint, who is a competitor, alleges arixmed, (b)6), is marketing an unapproved anti-choking device.Additionally, the website states the firm is fda registered, however, i can¿t find any registration.The complaint further alleges, they have purchased some of these devices and found they did not generate suction.
 
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Brand Name
APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
Type of Device
APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
Manufacturer (Section D)
ZHEJIANG LONGMED MEDICAL TECHNOLOGY CO., LTD.
MDR Report Key18758147
MDR Text Key335999557
Report NumberMW5151800
Device Sequence Number1
Product Code GCX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Unknown
Type of Report Initial
Report Date 02/20/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/21/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Patient Sequence Number1
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