MAUDE Adverse Event Report: ACTEGY LTD REVITIVE IX; CIRCULATION BOOSTER

Model Number IX

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Electric Shock (2554)

Event Date 09/12/2016

Event Type  Injury  

Manufacturer Narrative

After several attempts to contact the customer (mr (b)(6)) customer care managed to contact the mr (b)(6) on april 13, 2018 and confirmed the following: a) he had never visited his doctor or hospital concerning this reported incident.B) that he was suffering from poor circulation and had a self-expanding stent system put in and was not overweight.C) he had spoken to customer care on how best use the device, use lotion, keep hydrated and not turn the device up too high.D) admitted that initially he had not used the device correctly turning the intensity up too high.Following his conversation with customer care he was now using the device correctly as specified in the ifu to avoid a similar recurrence.E) his doctor is happy that his circulation has improved and that he continues to use the device.

Event Description

Please note: following an fda inspection at actegy ltd between march 5-8, 2018 by mr (b)(6) it was identified this incident should have been reported to fda.Therefore, the following incident is being reported retrospectively: customer reported "electric shock in his left foot that was painful and it also happened with the replacement.Right at the end of his big toe and after about ten minutes of use when he was on the phone with customer care.When he first used the replacement machine he suffered the shock sensation immediately.".

• Brand Name: REVITIVE IX
• Type of Device: CIRCULATION BOOSTER
• Manufacturer (Section D): ACTEGY LTD; reflex; cain road; bracknell, berkshire RG12 1HL; UK RG12 1HL
• Manufacturer Contact: lawrence brookfield ; reflex; cain road; bracknell, berkshire RG12 -1HL ; UK RG12 1HL
• MDR Report Key: 7549033
• MDR Text Key: 109391511
• Report Number: 3010078417-2018-00001
• Device Sequence Number: 1
• Product Code: NUH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K143207
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: IX
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 2 YR
• Event Location: Home
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Weight: 165