DRIVE MEDICAL UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-09 for DRIVE MEDICAL UNK manufactured by Unk.

Event Text Entries

[69557182] (b)(4) received a medwatch report (b)(4) in regards to the incident, involving an oxygen extension tubing, a product imported and distributed by (b)(4). The enduser allegedly became tangled up in her tubing causing her to fall. She was found by the staff at the facility. She allegedly complained of severe pain and was unable to move. She was taken to the hospital where an x-ray was performed. The x-ray showed a sub acute fracture of the proximal femur of the left leg. (b)(4) has been reaching out to the healthcare facility for product information to further investigate the complaint, however, this information is still not available at this time. Therefore we are unable to identify the manufacturer.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2438477-2017-00022
• MDR Report Key: 6393287
• Date Received: 2017-03-09
• Date of Report: 2017-02-07
• Date of Event: 2016-10-12
• Date Facility Aware: 2017-02-07
• Report Date: 2017-03-09
• Date Reported to FDA: 2017-03-09
• Date Added to Maude: 2017-03-09
• Event Key: 0
• Report Source Code: Distributor report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: DRIVE MEDICAL
• Generic Name: TUBING, NONINVASIVE
• Product Code: GAZ
• Date Received: 2017-03-09
• Model Number: UNK
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: UNK

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2017-03-09