MAUDE Adverse Event Report: KI MOBILITY LITTLE WAVE FLIP; LITTLE WAVE FLIP XP

Model Number	LITTLE WAVE FLIP
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	04/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the dealer who reported the complaint; "the incident was due to caregiver carelessness.The incident occurred during full assist transfer, pelvic belt was doff, and caregiver thought the release cables engaged the wheel lock system.The caregiver has taken full responsibility.".
Additional Manufacturer Narrative
According to the dealer who reported the complaint; "the incident was due to caregiver carelessness.The incident occurred during full assist transfer, pelvic belt was doff, and caregiver thought the release cables engaged the wheel lock system.The caregiver has taken full responsibility." we are reporting out of an abundance of caution as we were not able to determine whether the injury required hospital admission and therefore met the requirement for serious injury.

• Brand Name: LITTLE WAVE FLIP
• Common Device Name: LITTLE WAVE FLIP XP
• Manufacturer (Section D): KI MOBILITY; 5201 woodward dr; stevens point WI 54481
• Manufacturer Contact: kathy wirtz ; 5201 woodward drive; stevens point, WI 54481
• MDR Report Key: 19319667
• Report Number: 3005905321-2024-00006
• Device Sequence Number: 20748091
• Product Code: LBE
• UDI-Device Identifier: 00850013379132
• UDI-Public: (01)00850013379132(11)2023-05-09
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K223533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/15/2024

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
• Operator of Device: Lay User/Patient
• Device Model Number: LITTLE WAVE FLIP
• Device Catalogue Number: LITTLE WAVE FLIP XP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/29/2024
• Initial Report FDA Received Date: 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female