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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SHANGHAI SHUNLONG PHYSICAL THERAPY EQUIPMENT CO., DRIVE MEDICAL BED, MANUAL

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SHANGHAI SHUNLONG PHYSICAL THERAPY EQUIPMENT CO., DRIVE MEDICAL BED, MANUAL Back to Search Results
Model Number 15001ABV
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bone Fracture(s) (1870); Spinal Column Injury (2081)
Event Type  Injury  
Event Description
Drive devilbiss healthcare received noticed regarding the incident from the enduser's daughter, involving a bed rail, a product imported and distributed by drive devilbiss healthcare. While the enduser was in the bed, she allegedly fell out of the bed and sustained a compression fracture of the spine. The bed rail was down at the time of the incident because it allegedly didn't fit into the receiver. Drive devilbiss healthcare is in the process of getting the product back to further the investigation. This report is based on the information that was provided by the enduser's daughter.
 
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Brand NameDRIVE MEDICAL
Type of DeviceBED, MANUAL
Manufacturer (Section D)
SHANGHAI SHUNLONG PHYSICAL THERAPY EQUIPMENT CO.,
no. 259 jiugan road
sijing twn, song jiang distr.
shanghai shanghai, 20160 1
CH 201601
MDR Report Key6336302
MDR Text Key67599530
Report Number2438477-2017-00015
Device Sequence Number1
Product Code FNJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Patient Family Member or Friend
Type of Report Initial
Report Date 02/15/2017,01/18/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/16/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number15001ABV
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/15/2017
Distributor Facility Aware Date01/18/2017
Device Age7 MO
Event Location Home
Date Report to Manufacturer02/15/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 02/16/2017 Patient Sequence Number: 1
Treatment
DRIVE BED- ITEM# 15030
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