MAUDE Adverse Event Report: HANDICARE USA COMFORT RECLINE SPACER

Model Number 8E4230

Device Problems Break (1069); Torn Material (3024)

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

Event Date 12/08/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Initial/final report was sent on dec.12, 2016 to health (b)(4) for a comfort recline spacer h/s- xl sling investigated in (b)(4) on 10/31/16 via rga (b)(4).(b)(4) evaluated the sling.The pommel strap was not attached and was not included with the sling.The sling has broken threads where the pommel pouch connects to the main body of the sling.The pommel strap had been previously sewn on.The pommel strap is an optional feature added to the sling to keep the legs separated.Detachment does no present risk in use.The pommel pouch could become detached if: girth of leg is too large.The individual is not centered or the weight shifts during lifting.The individual is too heavy.The pommel strap has been attached to a hook on the carry bar, rather than being looped over the hip straps as shown above.Root cause: unable to establish definitive root cause of detachment.Corrective action: customer service contacted the customer to see if there were questions on the correct method of use for the comfort recline spacer sling and how to properly attach the pommel straps and pouch.They also reminded the customer there is an instructional video on the website that can be viewed.The comfort recline sling is sold with the pommel pouch added as an optional feature.Handicare us has implemented ecr 1219 to add sliders to the pommel so it can be adjusted for leg girth and shifting of weight.

Event Description

During a lift, using a comfort recline spacer sling, the pommel strap on used to keep the legs separated, detached from the sling.The shoulder and leg staps remained attached to the lift.The patient was lowered to the bed and was uninjured.

• Brand Name: COMFORT RECLINE SPACER
• Type of Device: COMFORT RECLINE SPACER
• Manufacturer (Section D): HANDICARE USA; 10888 metro court; maryland heights MO 63043
• Manufacturer (Section G): HANDICARE USA; 10888 metro court; maryland heights MO 63043
• Manufacturer Contact: rekha janarthanan ; 10888 metro court; maryland heights, MO 63043 ; 3142198642
• MDR Report Key: 7184432
• MDR Text Key: 97878376
• Report Number: 3007802293-2018-00003
• Device Sequence Number: 1
• Product Code: ILE
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nursing Assistant
• Device Model Number: 8E4230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/12/2017
• Initial Date FDA Received: 01/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 84 YR
• Patient Weight: 136