MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2015-12-09 for NEUROTECH KNEEHAB XP 412/421 0421-5032 manufactured by Bio-medical Research Ltd..
[32975399]
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.
Patient Sequence No: 1, Text Type: N, H10
[32975400]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020867-2015-00002 |
| MDR Report Key | 5276506 |
| Report Source | CONSUMER |
| Date Received | 2015-12-09 |
| Date of Report | 2015-11-24 |
| Date of Event | 2015-05-05 |
| Date Mfgr Received | 2015-06-10 |
| Device Manufacturer Date | 2013-11-11 |
| Date Added to Maude | 2015-12-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS ANNE-MARIE KEENAN |
| Manufacturer Street | PARKMORE BUSINESS PARK WEST |
| Manufacturer City | GALWAY, H91 NHT7 |
| Manufacturer Country | EI |
| Manufacturer Postal | H91 NHT7 |
| Manufacturer Phone | 91774316 |
| Manufacturer G1 | BIO-MEDICAL RESEARCH LTD. |
| Manufacturer Street | PARKMORE BUSINESS PARK WEST |
| Manufacturer City | GALWAY, H91 NHT7 |
| Manufacturer Country | EI |
| Manufacturer Postal Code | H91 NHT7 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEUROTECH KNEEHAB XP |
| Generic Name | POWERED MUSCLE STIMULATOR |
| Product Code | IPF |
| Date Received | 2015-12-09 |
| Returned To Mfg | 2015-07-27 |
| Model Number | 412/421 |
| Catalog Number | 0421-5032 |
| Lot Number | 1400420WE |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIO-MEDICAL RESEARCH LTD. |
| Manufacturer Address | PARKMORE BUSINESS PARK WEST GALWAY, H91 NHT7 EI H91 NHT7 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-12-09 |