MAUDE Adverse Event Report: STRYKER MEDICAL STRYKER CUB GENERAL PEDIATRIC CARE; STRETCHER, WHEELED

Model Number FL 19

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

Patient Problem Abrasion (1689)

Event Date 10/31/2019

Event Type  malfunction  

Event Description

Left thumb stuck in hospital bed canopy lock hole.Per family, they stepped out of the room and when they came back they found him with his left thumb stuck in the hole for the canopy lock station, to the 1st knuckle.A hospital staff member was able to remove the thumb after 20 minutes with maneuvering and vaseline.Patient¿s thumb has a superficial abrasion {not bleeding} and was able to move thumb independently.No obvious bony deformity.No other injury as a result.

• Brand Name: STRYKER CUB GENERAL PEDIATRIC CARE
• Type of Device: STRETCHER, WHEELED
• Manufacturer (Section D): STRYKER MEDICAL; 3800 e. centre avenue; portage MI 49002
• MDR Report Key: 9322247
• MDR Text Key: 166738583
• Report Number: MW5091083
• Device Sequence Number: 1
• Product Code: FPO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FL 19
• Device Catalogue Number: N/A
• Device Lot Number: FL 19 H
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 16 MO
• Patient Weight: 12