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

Catalog Number FL19

Device Problem Use of Device Problem (1670)

Patient Problem Injury (2348)

Event Date 05/07/2014

Event Type  Injury  

Event Description

A pediatric patient cut their finger when the patient stuck their finger in the hole that the protective top pins go into to close the top.

Manufacturer Narrative

A likely cause could not be identified as the unit met specifications at the time of the event.

Event Description

A pediatric patient cut their finger when the patient stuck their finger in the hole that the protective top pins go into to close the top.

• Brand Name: CUB
• 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: lucas fischhaber ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 3846086
• MDR Text Key: 4535981
• Report Number: 0001831750-2014-03035
• 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: Consumer
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/08/2014

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: Other
• Device Catalogue Number: FL19
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/08/2014
• Initial Date FDA Received: 06/03/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/11/2014
• 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 Age: 1 YR