MAUDE Adverse Event Report: GOODBABY 3 POSITION RECLINER (BASIC) JADE 9153641335; CHAIR AND TABLE, MEDICAL

Model Number IH6074A

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/20/2015

Event Type  malfunction  

Event Description

Bill states the chair was sent to the facility and ordered by a family member for the end user out of state, when delivered the right side frame was bent and all the way down the front castor is inward about three inches,out of box.Bill stated no damage to the box and chair has not been used by the end user.Bill was given the number to the provider belnick,inc to contact for service, bill states he did not have a contact number for the family member who ordered the chair, bill will contact the provider directly.No further information provided.

• Brand Name: 3 POSITION RECLINER (BASIC) JADE 9153641335
• Type of Device: CHAIR AND TABLE, MEDICAL
• Manufacturer (Section D): GOODBABY; CH
• MDR Report Key: 4457139
• MDR Text Key: 5322653
• Report Number: 1531186-2015-00595
• Device Sequence Number: 1
• Product Code: KMN
• 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: 01/26/2015,01/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: IH6074A
• 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: 01/26/2015
• Distributor Facility Aware Date: 01/21/2015
• Date Report to Manufacturer: 01/26/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other