MAUDE Adverse Event Report: JT POSEY COMPANY SINGLE PATIENT USE GAIT BELT; AID, TRANSFER

Model Number 6556

Device Problem Device Slipped (1584)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The product was requested to be returned and has not been received for evaluation.This report is based solely on the customer's reported issue.The instructions for use state: during the application of the belt "the strap should lay flat across the buckle.Tuck excess under the belt.Always verify proper closure before use.Always check for skin integrity, proper circulation and range of motion when the belt is in use.Ensure that the belt is secure and does not compromise the patient¿s medical condition and does not interfere with tubes, lines or other equipment." the device history record (dhr) of the affected serial number did not reveal any issues that could have contributed to the reported incident.No ncrs were identified.The device passed all verification testing and met manufacturing specifications prior to being released for distribution.Manufacturer reference file # (b)(4).Device has not yet been received.

Event Description

Customer reported the teeth do not have a secure fit when latched onto the material.Customer reported one instance when the teeth released from the material while in use with a patient but there were no injuries reported.The date of the incident is unknown.

Manufacturer Narrative

Conclusion: since the device was not returned for evaluation the reported issue could not be confirmed.Previous investigation found that the reported issue could only be observed when the product was not applied properly to the patient per the instructions for use.Simulation tests show that if step three (3) of the ifu is followed "tuck excess under the belt", "slippage" of the device is not observed.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 warnings for the safe and effective use of the device.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, spike, trends and any excursion above the control limits for this failure mode will be assessed, documented and acted upon as warranted.(b)(4).

Event Description

Supplement medwatch required for additional information.

• Brand Name: SINGLE PATIENT USE GAIT BELT
• Type of Device: AID, TRANSFER
• Manufacturer (Section D): JT POSEY COMPANY; 5632 peck road; arcadia CA 91006 0020
• Manufacturer (Section G): POSEY, S. DE R.L. DE C.V.; ave. ferrocarril no. 16901. bo; colonia rio tijuana, 3ra. etap; tijuana, mexico
• Manufacturer Contact: william hincy ; posey company; 5635 peck road; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 6071436
• MDR Text Key: 58927292
• Report Number: 2020362-2016-00046
• Device Sequence Number: 1
• Product Code: IKX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/05/2016

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: Nurse
• Device Model Number: 6556
• Device Catalogue Number: 6556
• Device Lot Number: 6168T002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/03/2016
• Initial Date FDA Received: 11/01/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1