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

Catalog Number UNK_MED

Device Problem Use of Device Problem (1670)

Patient Problem Pain (1994)

Event Date 04/17/2018

Event Type  Injury  

Manufacturer Narrative

The user facility stated that there were no defects with the mattress.

Event Description

It was reported that a woman on the cleaning staff at the hospital moved the mattress to clean the litter of the stretcher and when moving the mattress back into position from the side of the stretcher, she felt a sharp pain in her back.It was reported that the woman required occupational health therapy and was placed on light duty.It could not be confirmed if medications were prescribed.Additionally, the user facility could not confirm the model/serial number of the device the injury occurred with.

• 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: brian thompson ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 7515831
• MDR Text Key: 108353321
• Report Number: 0001831750-2018-00483
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2018
• 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
• Date Manufacturer Received: 04/17/2018
• 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