MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO CUB PEDIATRIC CRIB- FIXED BASE; BED, PEDIATRIC OPEN HOSPITAL

Catalog Number FL19F

Device Problem Positioning Failure (1158)

Patient Problems Bruise/Contusion (1754); Fall (1848)

Event Date 12/21/2021

Event Type  malfunction  

Event Description

It was reported that a patient fell from the crib and hit their head.As a result, the patient developed a knot on their head and needed a ct scan.Further information regarding the injury has not been provided yet.

Event Description

It was reported that a patient fell from the crib and hit their head.As a result, the patient developed a knot on their head and needed a ct scan.Further information regarding the injury has not been provided yet.

Manufacturer Narrative

The investigation is complete, and the executive summary and section h codes have been updated to reflect investigation results.

Event Description

It was reported that a patient fell from the crib and hit their head.The user facility stated that the patient's injuries were "minimal" and that the patient sustained some bruising.The patient required diagnostic imaging afterward, but no medical treatment was reported.

• Brand Name: CUB PEDIATRIC CRIB- FIXED BASE
• Type of Device: BED, PEDIATRIC OPEN 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: melanie shepard ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 13266391
• MDR Text Key: 285965390
• Report Number: 0001831750-2022-00004
• Device Sequence Number: 1
• Product Code: FMS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/29/2022

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?: Yes
• Device Catalogue Number: FL19F
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/21/2021
• Initial Date FDA Received: 01/17/2022
• Supplement Dates Manufacturer Received: 12/21/2021
• Supplement Dates FDA Received: 03/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other