MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO UNKNOWN_MEDICAL_PRODUCT; MATTRESS, FLOTATION THERAPY, NON-POWERED

Catalog Number UNK_MED

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Physical Entrapment (2327)

Event Date 09/14/2016

Event Type  Injury  

Event Description

A patient allegedly had their arm pinched between mattress and bed/siderail.It was alleged that the patient was lying on a mattress that was the incorrect size for the bed, which caused the nurse to have to give the side rail a hard push, which allegedly pinched the patient's arm.Allegedly the patient required surgery to fix the issue.No additional details regarding the injury or surgery were given.

Manufacturer Narrative

The issue was resolved for the customer by ensuring that no further feedback was required.

Event Description

A patient allegedly had their arm pinched between mattress and bed/siderail.It was alleged that the patient was lying on a mattress that was the incorrect size for the bed, which caused the nurse to have to give the side rail a hard push, which allegedly pinched the patient's arm.Allegedly the patient required surgery to fix the issue.No additional details regarding the injury or surgery were given.

• Brand Name: UNKNOWN_MEDICAL_PRODUCT
• Type of Device: MATTRESS, FLOTATION THERAPY, NON-POWERED
• 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: chanda burghard ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 6024507
• MDR Text Key: 57249282
• Report Number: 0001831750-2016-00318
• Device Sequence Number: 1
• Product Code: IKY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/03/2017

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: UNK_MED
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/14/2016
• Initial Date FDA Received: 10/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/03/2017
• 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