MAUDE Adverse Event Report: UNKNOWN CAREGUARD TOOL-LESS TRANSFER BENCH 2/CARTON 9153645723; ADAPTOR, HYGIENE

Model Number 98071

Device Problems Break (1069); Device Damaged Prior to Use (2284)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It has been reported by a dealer that the seat on a (b)(4) transfer bench arrived damaged.

• Brand Name: CAREGUARD TOOL-LESS TRANSFER BENCH 2/CARTON 9153645723
• Type of Device: ADAPTOR, HYGIENE
• Manufacturer (Section D): UNKNOWN; OH
• MDR Report Key: 4341367
• MDR Text Key: 5215282
• Report Number: 1531186-2014-06464
• Device Sequence Number: 1
• Product Code: ILS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Invalid Data
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 12/16/2014,11/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 98071
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/16/2014
• Distributor Facility Aware Date: 11/04/2014
• Date Report to Manufacturer: 12/16/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/18/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other