MAUDE Adverse Event Report: FOSHAN NANHAI R. POON MEDICAL PRODUCTS, CO. LTD. DRIVE MEDICAL; WALKER, MECHANICAL

Model Number R726BL

Device Problem Detachment Of Device Component (1104)

Patient Problems Contusion (1787); Fall (1848)

Event Date 05/28/2014

Event Type  Injury  

Event Description

(b)(4) received a complaint from the claimant's attorney on an incident involving a rollator imported and distributed by (b)(4).The claimant's attorney stated that the claimant was in her backyard on a concrete patio and she sat down on the unit, the right side wheel of the rollator allegedly became dislodged causing the claimant to fall and injure the right side of her face and body.Claimant went to the hospital.This mdr report is based on the information provided by the claimant's attorney.

• Brand Name: DRIVE MEDICAL
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): FOSHAN NANHAI R. POON MEDICAL PRODUCTS, CO. LTD.; foshan; guangdong 5282 16; CH 528216
• Manufacturer (Section G): MEDICAL DEPOT; 99 seaview blvd.; port washington NY 11050
• Manufacturer Contact: 99 seaview blvd.; port washington, NY 11050
• MDR Report Key: 4708903
• MDR Text Key: 5647097
• Report Number: 2438477-2015-00008
• Device Sequence Number: 1
• Product Code: ITJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 04/17/2015,07/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: R726BL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/18/2014
• Device Age: 1 YR
• Event Location: Home
• Date Report to Manufacturer: 04/17/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/20/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR
• Patient Weight: 87