XTREME BACK 1915 NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 1997-10-22 for XTREME BACK 1915 NA manufactured by Sunrise Mobility Products Division (jay Medical).

Event Text Entries

[111694] Reporter claims the back hardware broke during normal use.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1720745-1997-00003
• MDR Report Key: 127808
• Report Source: 00
• Date Received: 1997-10-22
• Date of Report: 1997-09-22
• Date of Event: 1997-09-01
• Date Mfgr Received: 1997-09-22
• Date Added to Maude: 1997-10-24
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Single Use: 3
• Remedial Action: IN
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: XTREME BACK
• Generic Name: WHEELCHAIR BACK
• Product Code: KNO
• Date Received: 1997-10-22
• Returned To Mfg: 1997-09-24
• Model Number: 1915
• Catalog Number: NA
• Lot Number: NA
• ID Number: NA
• Operator: LAY USER/PATIENT
• Device Availability: R
• Device Eval'ed by Mfgr: Y
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 125037
• Manufacturer: SUNRISE MOBILITY PRODUCTS DIVISION (JAY MEDICAL)
• Manufacturer Address: 7477 EAST DRY CREEK PKWY. LONGMONT CO 80503 US
• Baseline Brand Name: XTREME BACK
• Baseline Generic Name: WHEELCHAIR ACCESSORY (89 KNO)
• Baseline Model No: 1915
• Baseline Catalog No: NA
• Baseline ID: NA
• Baseline Device Family: WHEELCHAIR ACCESSORY (89 KNO)
• Baseline Shelf Life [Months]: NA
• Baseline PMA Flag: N
• Baseline 510K PMN: N
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: N

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1997-10-22