MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. NON-ACP TEMPUR-PEDIC 8-PIECE PAD SET; PATIENT SUPPORT AND POSITIONING PAD

Model Number 6957

Device Problems Device Issue (2379); Device Operates Differently Than Expected (2913)

Patient Problem Pressure Sores (2326)

Event Date 01/07/2016

Event Type  Injury  

Manufacturer Narrative

Device not returned.

Event Description

Following a lumbar decompression procedure (l4 - s1), which lasted almost 12 hours (7:50 am - 7:11 pm), the patient had severe pressure sores, reddish and purple in color in 4 areas (right and left flanks, as well as right and left thighs).There was diffuse blistering on the right flank, and a 1-inch skin tear on the left thigh.All of the marks were the same size and location of the pads.No p-kits or pad covers were used.

Manufacturer Narrative

The visco-elastic properties of the pads will help to reduce pressure issues; however, this feature will not eliminate them altogether.Proper positioning and regular monitoring of the patient are needed to ensure pressure issues and nerve damage are minimized.In addition, the length of the case at 11+ hours was likely a contributing factor to the pressure ulcers experienced by the patient.The aorn "recommended practices for positioning a patient in the perioperative setting" emphasizes the importance of adequate padding, assessment, and monitoring for patient safety.The owner's manual also cautions users about assessment and monitoring of the patient's positioning.A follow-up in-service was completed on (b)(6) 2016; offered to help address any further concerns or questions around patient positioning.Device not returned.

Event Description

Following a lumbar decompression procedure (l4 - s1), which lasted almost 12 hours (7:50 am - 7:11 pm), the patient had severe pressure sores, reddish and purple in color in 4 areas (right and left flanks, as well as right and left thighs).There was diffuse blistering on the right flank, and a 1-inch skin tear on the left thigh.All of the marks were the same size and location of the pads.No p-kits or pad covers were used.

• Brand Name: NON-ACP TEMPUR-PEDIC 8-PIECE PAD SET
• Type of Device: PATIENT SUPPORT AND POSITIONING PAD
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern avenue; union city CA 94587 1234
• Manufacturer (Section G): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern avenue; union city CA 94587 1234
• Manufacturer Contact: anne leblanc ; 30031 ahern avenue; union city, CA 94587-1234 ; 5104291500
• MDR Report Key: 5381706
• MDR Text Key: 36464963
• Report Number: 2921578-2016-00004
• Device Sequence Number: 1
• Product Code: FWZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 6957
• Device Catalogue Number: 6957
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Other
• Patient Age: 59 YR
• Patient Weight: 113