MAUDE Adverse Event Report: GOODBABY 3 POSITION RECLINER-DELUXE ADULT BLUE RIDGE 9153641331; CHAIR AND TABLE, MEDICAL

Model Number IH6065A/IH61

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Dealer is stating concealed damage, the lower frame on the left side is bent inwards, no damage to the box.S/n (b)(4).

• Brand Name: 3 POSITION RECLINER-DELUXE ADULT BLUE RIDGE 9153641331
• Type of Device: CHAIR AND TABLE, MEDICAL
• Manufacturer (Section D): GOODBABY; CH
• MDR Report Key: 4348518
• MDR Text Key: 5204624
• Report Number: 1531186-2014-06539
• Device Sequence Number: 1
• Product Code: FRK
• 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: 12/17/2014,12/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: IH6065A/IH61
• 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: 12/17/2014
• Distributor Facility Aware Date: 12/01/2014
• Device Age: 3 MO
• Date Report to Manufacturer: 12/17/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other