MAUDE Adverse Event Report: POSEY PRODUCTS LLC EZ CLEAN GAIT BELTS W/SPRING-LOADED BUCKLE; AID, TRANSFER

Model Number 6546B

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Product is scheduled to be returned but has not been received in for evaluation.Therefore, this report is based solely on the information provided by the customer.At this time, there is no evidence that a manufacturing non-conformity contributed to the reported complaint and the instructions for use were reviewed and determined to provide adequate instructions and warning for the safe and effective use of the device.Therefore, no corrective and or preventative actions are necessary.All complaints are trended and reviewed by management on a monthly basis.As part of this monthly review, any excursion above the control limits for this failure mode will be assessed, documented and acted upon as warranted.(b)(4).No product returned at this time.

Event Description

Customer reported it is difficult to get secure closure around the patient, it takes 2 hands and lots of readjustment.This creates an unsafe situation when the patient stands and the belt needs to be readjusted frequently.The date the issue was discovered is unknown.No patient injury was reported.

Event Description

Supplemental required for additional information.

Manufacturer Narrative

Evaluation codes : customer confirmed they will not be returning the product.Without return of the device, the reported issue could not be confirmed and failure could not be determined.However, customer provided additional clarification and stated there was no product malfunction.Historical review of the complaint database, showed five other similar complaints but there was no report of any serious injury and no product was returned for analysis with any of the complaints.Sample evaluations did not confirm any of the reported issues as the samples pulled from inventory functioned as expected.The instructions for use warn the user to "always inspect before each use: check for broken stitches or parts; torn, cut or frayed material; or buckles that are cracked or broken and do not hold securely.Never use soiled or damaged products." at this time, there is no evidence that a manufacturing non-conformity contributed to the reported complaint.Therefore, no corrective or preventative actions are necessary.All complaints are trended and reviewed by management on a monthly basis.As part of this monthly review, any excursion above the control the limits for this failure mode will be assessed, documented and acted upon as warranted.Manufacturer reference file #(b)(4).

• Brand Name: EZ CLEAN GAIT BELTS W/SPRING-LOADED BUCKLE
• Type of Device: AID, TRANSFER
• Manufacturer (Section D): POSEY PRODUCTS LLC; 5635 peck rd; arcadia 91006
• MDR Report Key: 7474260
• MDR Text Key: 107204688
• Report Number: 2020362-2018-00026
• Device Sequence Number: 1
• Product Code: IKX
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 05/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 6546B
• Device Catalogue Number: 6546B
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1