MAUDE Adverse Event Report: TIDI PRODUCTS, LLC POSEY BEVELED FLOOR CUSHION; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number 6027

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Limb Fracture (4518)

Event Date 01/06/2023

Event Type  Injury  

Event Description

Tidi received a letter in the mail from gust rosenfeld law office indicating they received a letter from another lawyer stating their client had slipped on a posey fall mat while visiting her son in the hospital.She fractured her wrist due to the fall.Letter states: she came in the room and placed her purse on a chair and then turned her body, during the process of turning the front of her foot caught against the mat placed on the side of her sons bed.She also indicates lower back injuries.

Manufacturer Narrative

H3 the product is scheduled to be returned but has not been received in by manufacturer at the time of this report.Tidi was notified by gust rosenfeld law office of a potential claim with a posey floor cushion.This report is based solely on the allegations that resulted in a patient fall with serious injuries.An attempt was made to contact the user facility to collect information surrounding the event and to confirm the product part number.Email communication was also sent to peter collins, an attorney at gust rosenfeld law office, in an effort to gather information surrounding the incident and to get product returned for investigation.Peter collins, lawyer investigating the case was able to confirm there was no device malfunction and that the product will be returned to tidi products for investigation.The product lot information was not provided, therefore the release documentation could not be reviewed.Instructions for use (ifu) were reviewed and found to provide adequate instructions and warnings for safe and effective use of the device.Intended use of the floor cushions are to reduce the risk of injury due to a patient fall from the bed.They are indicated for patients who are at high risk of fall-related injuries from the bed.Warnings state to inform residents and staff to take care when stepping on or off of the cushion to avoid tripping.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 limits for this failure mode will be assessed, documented and acted upon as warranted manufacturer reference file (b)(4).

• Brand Name: POSEY BEVELED FLOOR CUSHION
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): TIDI PRODUCTS, LLC; 570 enterprise drive; neenah WI 54956
• Manufacturer Contact: chris rahn ; 570 enterprise drive; neenah, WI 54956 ; 9207514300
• MDR Report Key: 16919564
• MDR Text Key: 315096210
• Report Number: 2182318-2023-00037
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 10190676000439
• UDI-Public: 10190676000439
• 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: Other,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 6027
• Device Catalogue Number: 6027
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/14/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female