MAUDE Adverse Event Report: HANDICARE BATHROOM SAFETY B.V. HINGED ARM SUPPORT 800; ADAPTOR, HYGIENE

Model Number LI2603.3802-02

Device Problems Defective Device (2588); Device Dislodged or Dislocated (2923); Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/01/2016

Event Type  malfunction  

Event Description

Handicare was notified of two separate malfunctioning hinged arm supports (has) on (b)(6) 2016.Both involved the grab handle dislodging from the has when the patients were attempting to stand up.One patient fell to the floor and the other was able to stand up, but the has fell on the patient's foot.The reporting facility did not provide patient injuries sustained during both malfunctions.

• Brand Name: HINGED ARM SUPPORT 800
• Type of Device: ADAPTOR, HYGIENE
• Manufacturer (Section D): HANDICARE BATHROOM SAFETY B.V.; weteringweg 9; pijnacker, 2641 KM; NL 2641 KM
• Manufacturer (Section G): HANDICARE BATHROOM SAFETY B.V.; weteringweg 9; pijnacker, 2641 KM; NL 2641 KM
• Manufacturer Contact: yi-qin bu ; torshamnsgatan 35; kista, 164 4-0 ; SW 164 40 ; 6855762200
• MDR Report Key: 6157821
• MDR Text Key: 62379144
• Report Number: 3009481053-2016-00009
• Device Sequence Number: 1
• Product Code: ILS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 12/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: LI2603.3802-02
• Device Lot Number: 02/15
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1