SAFHS 2000 MOU ASSEMBLY UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2013-07-25 for SAFHS 2000 MOU ASSEMBLY UNK manufactured by Bioventus Llc.

Event Text Entries

[3840341] It was reported that following treatment with the exogen device, the pt experienced a case of eczema. The physician relates the reaction to the gel. This complaint was reported to the pmda on (b)(6) 2013.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3010203571-2013-00002
• MDR Report Key: 3311016
• Report Source: 08
• Date Received: 2013-07-25
• Date of Report: 2015-07-15
• Date of Event: 2013-06-07
• Date Added to Maude: 2013-09-05
• 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: 0
• Event Location: 0
• Manufacturer Contact: KANICHY ROYSTON
• Manufacturer Street: 1900 CHARLES BRYAN RD SUITE 275
• Manufacturer City: CORDOVA TN 38016
• Manufacturer Country: US
• Manufacturer Postal: 38016
• Manufacturer Phone: 9013412930
• Manufacturer G1: BIOVENTUS LLC
• Manufacturer Street: 1900 CHARLES BRYAN RD SUITE 275
• Manufacturer City: CORDOVA TN 38016
• Manufacturer Country: US
• Manufacturer Postal Code: 38016
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: SAFHS 2000 MOU ASSEMBLY
• Generic Name: BONE GROWTH STIMULATOR/LPQ
• Product Code: LPQ
• Date Received: 2013-07-25
• Model Number: NA
• Catalog Number: UNK
• Lot Number: NA
• ID Number: NA
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BIOVENTUS LLC
• Manufacturer Address: CORDOVA TN 38016 US 38016

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2013-07-25