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

Catalog Number FL19F

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

Patient Problems Head Injury (1879); Injury (2348)

Event Date 10/11/2018

Event Type  malfunction  

Event Description

It was reported that a young patient fell out of a crib and sustained injuries to the face and head.The patient underwent a ct following the alleged incident.

Manufacturer Narrative

The customer could not identify which specific unit this event had occurred on.The child had fallen through the front gate and sustained a cut to his lip.A ct scan was performed for precautionary measures.The injury was treated simply with ice and no medical intervention was necessary.The customer had confirmed that this was a user error and that they provided retraining to the staff.

Event Description

It was reported that a young patient fell out of a crib and sustained injuries to the face and head.

• 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: brian thompson ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 8053429
• MDR Text Key: 126632355
• Report Number: 0001831750-2018-01426
• 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: 01/07/2019

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
• Device Operator: No Information
• Device Catalogue Number: FL19F
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/11/2018
• Initial Date FDA Received: 11/08/2018
• Supplement Dates Manufacturer Received: 10/11/2018
• Supplement Dates FDA Received: 01/07/2019
• Was Device Evaluated by Manufacturer?: No
• 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