MAUDE Adverse Event Report: POSEY PRODUCTS LLC POSEY MISCELLANEOUS

Model Number MISC

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Fall (1848)

Event Date 04/21/2018

Event Type  Injury  

Manufacturer Narrative

Product is scheduled to be returned but has not been received in for evaluation at the time of this report.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 posey mats 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 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.Manufacturer reference file #(b)(4).

Event Description

Customer reported a nurse slipped and fell while using one of the posey fall mats.The employee slipped and fell due to a liquid spill that got under the mat and the mat slid when the employee stepped on it.The nurse twisted her left knee but have not sought any medical treatment at the time of this report.No other information is available.

Manufacturer Narrative

Additional information provided by the customer confirmed the product part number.Customer also confirmed the product will not be returning, therefore, this report is based solely on the information provided by the customer.An investigation of similar complaints found two other events where it was reported the nurse fell when the floor cushion slipped.Customer confirmed there was no product non-conformity.Also confirmed the customer is aware of the instruction for use's recommendation of cleaning up spills to avoid the mat slipping.At this time there is no evidence that a manufacturing non-conformity contributed to the reported complaint and the instructions for use (ifu) were reviewed and determined to provide adequate instructions and warnings for the safe and effective use of the device.The ifu states "inform resident and staff to take care when stepping on or off of the cushion to avoid tripping.Follow your facility¿s procedures for cleaning spills in patient care areas.Do not place floor cushions on or around damp or wet areas.Clean spills on, around or under floor cushions.Liquids under floor cushions may cause a slip and fall accident." therefore, no corrective or preventive actions are necessary.All complaints are trended on a monthly bases.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.Manufacturer reference file #(b)(4).

Event Description

Supplemental required for additional information.

• Brand Name: POSEY MISCELLANEOUS
• Manufacturer (Section D): POSEY PRODUCTS LLC; 5635 peck rd; arcadia CA 91006
• Manufacturer Contact: william hincy ; posey company; 5635 peck road; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 7523237
• MDR Text Key: 108731995
• Report Number: 2020362-2018-00032
• Device Sequence Number: 0
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/31/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Nurse
• Device Model Number: MISC
• Device Catalogue Number: MISC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2018
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Other