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

Catalog Number FL19H

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 04/02/2018

Event Type  Injury  

Manufacturer Narrative

No defect alleged.

Event Description

It was reported that a hospital staff member unlocked the brake of the stretcher, it then swung around somehow and the lower portion of the stretcher cut their leg.It was reported that the cut required stitches.

• Brand Name: CUB PEDIATRIC CRIB- HYD 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: 7907467
• MDR Text Key: 121701642
• Report Number: 0001831750-2018-01062
• Device Sequence Number: 1
• Product Code: FMS
• UDI-Device Identifier: 07613327169348
• UDI-Public: 07613327169348
• 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
• Report Date: 09/25/2018

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: FL19H
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/28/2018
• Initial Date FDA Received: 09/25/2018
• 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