MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO M-1 COT - BASE HIGH LOAD 28; STRETCHER, WHEELED

Catalog Number 6100003000

Device Problem Component Falling (1105)

Patient Problems Bruise/Contusion (1754); Hematoma (1884); Injury (2348)

Event Date 02/11/2018

Event Type  Injury  

Event Description

It was alleged that while loading the cot and patient, the cot tipped over and dropped to the ground.The patient received a cranial bruise and hematoma on the head.No further medication or medical therapy has been reported at this time.

Manufacturer Narrative

No defects were found that would have caused or contributed to the alleged issue.

Event Description

It was alleged that while loading the cot and patient, the cot tipped over and dropped to the ground.The patient received a cranial bruise and hematoma on the head.No further medication or medical therapy has been reported at this time.

Manufacturer Narrative

Supplemental submitted to include udi.

Event Description

It was alleged that while loading the cot and patient, the cot tipped over and dropped to the ground.The patient received a cranial bruise and hematoma on the head.No further medication or medical therapy has been reported at this time.

• Brand Name: M-1 COT - BASE HIGH LOAD 28
• Type of Device: STRETCHER, WHEELED
• 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: kristen canter ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 7268373
• MDR Text Key: 99984835
• Report Number: 0001831750-2018-00096
• Device Sequence Number: 1
• Product Code: FPO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 6100003000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/13/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/30/2012
• 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