MAUDE Adverse Event Report: BIO-MEDICAL RESEARCH LTD. NEUROTECH KNEEHAB XP; POWERED MUSCLE STIMULATOR

Model Number 412/421

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

Patient Problem Wound Dehiscence (1154)

Event Date 05/05/2015

Event Type  Injury  

Manufacturer Narrative

The returned device was functioning as expected.Instructions for use not followed.Section 2.2 precautions of ifu , bullet point 6, states, "caution should be used in the presence of the following - following recent surgical procedures when muscle contraction may disrupt the healing process;" this patient was using the device on (b)(6) 2015 when he had surgery on his knee on (b)(6) 2015 which is 8 days previous.

Event Description

Patient was prescribed the left kneehab xp from his doctor in (b)(6) 2015.Patient advised he had knee surgery on (b)(6) 2015 and used the unit 1 day 05/05/15 x 3 times.Also stated that he had a bandage over the wound but it was not directly underneath the kneehab.The third time he went to use it he went to the bathroom shortly afterwards and noticed blood coming down his leg.Patient contacted his doctor straight away.He was advised to cease using it and he stated using the kneehab resulted in his wound reopening and he needed his doctor to reclose the wound.

• Brand Name: NEUROTECH KNEEHAB XP
• Type of Device: POWERED MUSCLE STIMULATOR
• Manufacturer (Section D): BIO-MEDICAL RESEARCH LTD.; parkmore business park west; galway, H91 N HT7; EI H91 NHT7
• Manufacturer (Section G): BIO-MEDICAL RESEARCH LTD.; parkmore business park west; galway, H91 N HT7; EI H91 NHT7
• Manufacturer Contact: anne-marie keenan ; parkmore business park west; galway, H91 N-HT7 ; EI H91 NHT7 ; 91774316
• MDR Report Key: 5276506
• MDR Text Key: 32975399
• Report Number: 8020867-2015-00002
• Device Sequence Number: 1
• Product Code: IPF
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K110350
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 11/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 412/421
• Device Catalogue Number: 0421-5032
• Device Lot Number: 1400420WE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Home
• Date Manufacturer Received: 06/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 87 YR