HANEL 0T25050

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2007-05-11 for HANEL 0T25050 manufactured by .

Event Text Entries

[8137839] Rep said this arm fell down in the room when the cleaning crew was mopping the floor. Cleaner claims that he didn't touch it, it simply fell of its own volition. No injury claimed. We have requested arm to be returned for inspection 6/27. Please note: the brand of the mavig arm is "hanel" not portegra as stated in this report. 7/21 - rec'd arms for inspection. They show signs of heavy abuse (missing paint and scratching) indicative of being in repeated collisions. This is consistent with the arms finally breaking.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 2438931-2007-00002
• MDR Report Key: 1253102
• Report Source: 06
• Date Received: 2007-05-11
• Device Manufacturer Date: 1997-11-01
• Date Added to Maude: 2008-12-09
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 0
• Reprocessed and Reused Flag: 3
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 0
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Manufacturer Phone: **
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Remedial Action: IN
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: HANEL
• Product Code: KPY
• Date Received: 2007-05-11
• Model Number: 0T25050
• Device Eval'ed by Mfgr: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 837813

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2007-05-11