MAUDE Adverse Event Report: NOVA 1470 BEACHEY PLACE, CARSON, CA 90746 AID, TRANSFER

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Fall (1848)

Event Type  Injury  

Event Description

The caller stated the suction cups are not sticking to the tub.Customer called back and spoke to another rep and advised the product is actually a nova brand.She states she had the instructions from her old invacare model, which broke a few years ago, and she got the nova as a replacement.She alleged that in the nova model she had fallen and hurt her shoulder, but she was having a rough time explaining that to the csr.The customer was unable to provide a lot or model from the nova bench.The invacare bench is no longer in service and a serial number will not be available.Invacare prid#(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: AID, TRANSFER
• Type of Device: AID, TRANSFER
• Manufacturer (Section D): NOVA 1470 BEACHEY PLACE, CARSON, CA 90746
• MDR Report Key: 17530613
• MDR Text Key: 321100541
• Report Number: MW5137531
• Device Sequence Number: 1
• Product Code: IKX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1