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

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.

• Brand Name: DRIVE MEDICAL
• Type of Device: BED, 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 Key: 6336302
• MDR Text Key: 67599530
• Report Number: 2438477-2017-00015
• Device Sequence Number: 1
• Product Code: FNJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 02/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 15001ABV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/15/2017
• Distributor Facility Aware Date: 01/18/2017
• Device Age: 7 MO
• Event Location: Home
• Date Report to Manufacturer: 02/15/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: DRIVE BED- ITEM# 15030
• Patient Outcome(s): Other
• Patient Age: 83 YR
• Patient Weight: 47