MAUDE Adverse Event Report: GOODBABY CLINICAL RECLINER BLUE RIDGE 9153641321; CHAIR AND TABLE, MEDICAL

Model Number IH6077A/IH61

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Consumer states the brand new chair has a cracked right side panel.

• Brand Name: CLINICAL RECLINER BLUE RIDGE 9153641321
• Type of Device: CHAIR AND TABLE, MEDICAL
• Manufacturer (Section D): GOODBABY; CH
• MDR Report Key: 4406890
• MDR Text Key: 18064575
• Report Number: 1531186-2015-00166
• 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: Patient
• Type of Report: Initial
• Report Date: 01/09/2015,12/22/2014

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: IH6077A/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: 01/09/2015
• Distributor Facility Aware Date: 12/22/2014
• Device Age: 5 MO
• Date Report to Manufacturer: 01/09/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/12/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other