STAXI WHEELCHAIR

Report

• Report Number: MW5181231
• Event Type: Malfunction
• Date Received: December 29, 2025
• Report Date: December 18, 2025
• Manufacturer: THREE BEARS (JIANGSU) HEALTHCARE TECHNOLOGY CO. LTD.
• Product Code: INN
• Product Problem: Yes
• Report Source: Voluntary report
• Reporter Occupation: UNKNOWN
• Health Professional: *

Narratives

Description of Event or Problem · 0

STRYKER MEDICAL WAS NOTIFIED OF A POTENTIALLY REPORTABLE COMPLAINT INVOLVING A PRODUCT FOR WHICH STRYKER IS NOT THE ORIGINAL EQUIPMENT MANUFACTURER OF THE REPORTED DEVICE. THE CUSTOMER ALLEGED A MANUFACTURER STAXI WHEELCHAIR, SERIAL NUMBER (B)(6) THAT HAD A SEAT SECTION THAT WOULD NOT HOLD PATIENT WEIGHT. PLEASE FIND ADDITIONAL CONTACT INFORMATION BELOW. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1917718	STAXI WHEELCHAIR	CHAIR, ADJUSTABLE, MECHANICAL	INN	THREE BEARS (JIANGSU) HEALTHCARE TECHNOLOGY CO. LTD.

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown

Terms

Patient problem · 1

• No Clinical Signs, Symptoms or Conditions

Product problems · 1

• Use of Device Problem

Type of report · 1

• Initial submission