MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05 report with the FDA on 2012-05-23 for HIVAMAT 200 050 manufactured by Physiomed Elektromedizin Ag.
[2725590]
Pain in right area of leg/hip, inguinal, quadriceps radiating to knee, also lumbarcoxic pain, pain after treatment (treatment was after training with the device, trainee 3 people, training on that person several times) later cold shivering and cold extremities, swelling (later) we are not able to comprehend or verify the described swelling or pain.
Patient Sequence No: 1, Text Type: D, B5
[10114539]
The hivamat 200 devices have been on the market for 20 years (europe), respectively since 2004 (usa). A comparable side effect or event as the one described has never been reported to the mfr. From our experience and the experience of our medial consultants, it is very unlikely that the physiological effect of the device can be the cause of a symptomatology as described by the pt. The device has a very low risk level and is classified as class i device, exempt, registered with fda as such the lady has a very long list of medical complaints, one of which or several of which might be the cause of the pain which she continues to feel; we are not able to comprehend or to verify the pain or swelling. We were informed about the event for the first time in the middle of january 2012. At that time we did not have the details we know today. With the info we had then we did not see a reason to make a reporting to the fda yet. Later we were informed that the event occurred during/after a training with the device for a clinic? S medical personnel. The trainer is a person who has already been in contact with the medical team for years and had conducted several previous trainings with the team since 2010. The pt in question is a member of this team. She had previously undergone several hivamat 200 treatments for pain and a swollen knee, which all were successful and without complaints. In january the pt reported uncomfortable sensations during and pain after the training session (event). It must be taken into account that the pt has a long medial history of different diagnoses. The device in question was tested. No irregularities or deviations were observed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002892330-2012-00001 |
| MDR Report Key | 2623682 |
| Report Source | 04,05 |
| Date Received | 2012-05-23 |
| Date of Report | 2012-03-16 |
| Date of Event | 2012-02-28 |
| Date Mfgr Received | 2012-02-28 |
| Device Manufacturer Date | 2011-09-01 |
| Date Added to Maude | 2012-08-03 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | HUTWEIDE 10 |
| Manufacturer City | SCHNAITTACH/LAIPERSDORF 91220 |
| Manufacturer Country | GM |
| Manufacturer Postal | 91220 |
| Manufacturer Phone | 12625870 |
| Manufacturer G1 | PHYSIOMED ELEKTROMEDIZIN AG |
| Manufacturer Street | HUTWEIDE 10 |
| Manufacturer City | SCHNAITTACH/LAIPERSDORF |
| Manufacturer Country | GM |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HIVAMAT 200 |
| Generic Name | HIVAMAT 200 |
| Product Code | ISA |
| Date Received | 2012-05-23 |
| Returned To Mfg | 2012-02-24 |
| Model Number | 050 |
| Catalog Number | 050 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHYSIOMED ELEKTROMEDIZIN AG |
| Manufacturer Address | HUTWEIDE 10 SCHNAITTACH/LAIPERSDORF GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-05-23 |