N/A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a * report with the FDA on 2012-04-06 for N/A manufactured by Ebi, Llc.

Event Text Entries

[19582931] It was reported that the osteogen device caused serious injury to patient. Patient outcome: not verified.
Patient Sequence No: 1, Text Type: D, B5

[19594094] Patient has complained of numerous afflictions and believes them all to be related to implanted device. Patient's physicians have not corroborated reported afflictions. Device still implanted in patient.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 0002242816-2012-00031
• MDR Report Key: 2521809
• Report Source: *
• Date Received: 2012-04-06
• Date of Report: 2012-03-07
• Date Mfgr Received: 2012-03-07
• Date Added to Maude: 2012-04-09
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Manufacturer Contact: ART KAUFMAN
• Manufacturer Street: 100 INTERPACE PARKWAY
• Manufacturer City: PARSIPPANY NJ 07054
• Manufacturer Country: US
• Manufacturer Postal: 07054
• Manufacturer Phone: 9732999300
• Manufacturer Country: US
• Single Use: 3
• Previous Use Code: 3
• Removal Correction Number: N/A
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: N/A
• Product Code: LOE
• Date Received: 2012-04-06
• Model Number: N/A
• Catalog Number: N/A
• Lot Number: N/A
• ID Number: N/A
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: EBI, LLC
• Manufacturer Address: 100 INTERPACE PARKWAY PARSIPPANY NJ 07054 US 07054

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Deathisabilit	2012-04-06