MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO ISOFLEX LAL 2860 AFTERMARKET; BED, FLOTATION THERAPY, POWERED

Catalog Number 2860000999

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Pressure Sores (2326)

Event Date 12/12/2018

Event Type  Injury  

Manufacturer Narrative

Customer is not alleging a product malfunction.

Event Description

It was reported that the user facility alleges a general increase in pressure injuries.No specific incidents were reported.

• Brand Name: ISOFLEX LAL 2860 AFTERMARKET
• Type of Device: BED, FLOTATION THERAPY, 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: mary klaver ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 8232304
• MDR Text Key: 132566967
• Report Number: 0001831750-2019-00003
• Device Sequence Number: 1
• Product Code: IOQ
• 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: 01/09/2019

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: 2860000999
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/12/2018
• Initial Date FDA Received: 01/09/2019
• 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