MAUDE Adverse Event Report: Stryker Medical-Kalamazoo NARA, DOMESTIC; BASSINET, HOSPITAL

Catalog Number	4402000001
Medical Device Problem Code	Material Too Soft/Flexible (4007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction

• Brand Name: NARA, DOMESTIC
• Common Device Name: BASSINET, HOSPITAL
• Manufacturer (Section D): Stryker Medical-Kalamazoo; 3800 east centre avenue; portage MI 49002
• Manufacturer (Section G): Stryker Medical-Kalamazoo; 3800 east centre avenue; portage MI 49002
• Manufacturer Contact: brandon luckas ; 3800 east centre avenue; portage, MI 49002 ; +1(269)329-2100
• MDR Report Key: 50060199
• Report Number: 0001831750-2026-99417
• Device Sequence Number: 10665794
• Product Code: NZG
• UDI-Device Identifier: 07613327261615
• UDI-Public: 07613327261615
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 3
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 07/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 4402000001
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/01/2026
• Initial Report FDA Received Date: 07/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown