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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PINGHU WEIFENG MATERIAL TECHNOLOGY DAILY ACTIVITY ASSIST DEVICES; 890.5050

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PINGHU WEIFENG MATERIAL TECHNOLOGY DAILY ACTIVITY ASSIST DEVICES; 890.5050 Back to Search Results
Model Number 96-2
Device Problem Deformation Due to Compressive Stress (2889)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/22/2014
Event Type  No Answer Provided  
Event Description
It was reported by the provider that the legs on this unit is bowing out which is making the unit unstable.No patient injury reported, no additional information provided.
 
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Brand Name
DAILY ACTIVITY ASSIST DEVICES
Type of Device
890.5050
Manufacturer (Section D)
PINGHU WEIFENG MATERIAL TECHNOLOGY
pinghu
CH 
MDR Report Key4093673
MDR Text Key18542143
Report Number1531186-2014-04160
Device Sequence Number1
Product Code IKX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Invalid Data
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 09/16/2014,08/26/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/16/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number96-2
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/16/2014
Distributor Facility Aware Date08/26/2014
Device Age8 MO
Date Report to Manufacturer09/16/2014
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Weight84
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