MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,06,07 report with the FDA on 2011-04-29 for HYBRESIS 199589-001 manufactured by Empi, Inc..
[1851398]
It was reported that a patient received a 3rd degree burn on top of her right foot while using an empi hybresis device; this was the 4th treatment. The compound used was dexamethasone at 4mg/ml, and 1. 5 ml was used on the patch. The medication was placed on the negative side and saline was placed on the positive side of the patch. The mode used was "hybresis", and the dose controller was on for 3 minutes, and the patch was worn for 2 hours. Before the treatment the patient had an ultrasound, and myofascial release of the lower leg. A coban wrap was used to wrap over the electrode, and the patient put a tennis shoe on. The patient reported having severe pain and tried to leave the patch on and tolerate the pain. When the patch was removed the patient noticed a burn under the patch and returned to the clinic. She was instructed to follow up with her md; she saw her md the next day. The burn was noted as being 3rd degree, and by the pictures sent the burn looks to be 1cm in diameter. Wound was debrided.
Patient Sequence No: 1, Text Type: D, B5
[9042564]
The actual device was not returned for evaluation. Three unused patches of the same lot number were returned. All met physical and electrical specifications. The user manual for the hybresis patch states: advise the patient to remove electrodes if any undue sensation of pain or burning occurs during the treatment and to report discomfort to clinic. Apply the hydrated patch so that the drug pad is over the treatment site and secure it by pressing the adhesive border. Avoid pressing directly over the pads. Pressing directly on the pads can cause leakage that will compromise adhesion to the patient. Note: do not tape or bind the patch during treatment. Do not apply hot or cold therapy over patch during treatment. The device history record was reviewed, and the lot of patches met all released specifications. This incident is similar to a complaint received by empi that suggests that this device may have malfunctioned in such a way that it could have contributed to this injury.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1721293-2011-00002 |
| MDR Report Key | 2073089 |
| Report Source | 04,06,07 |
| Date Received | 2011-04-29 |
| Date of Report | 2011-04-28 |
| Date of Event | 2011-03-23 |
| Date Mfgr Received | 2011-03-31 |
| Device Manufacturer Date | 2010-12-01 |
| Date Added to Maude | 2011-04-29 |
| 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 | PHYSICAL THERAPIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. DEBBIE MIRANDA |
| Manufacturer Street | 205 HWY 22 EAST |
| Manufacturer City | CLEAR LAKE SD 57226 |
| Manufacturer Country | US |
| Manufacturer Postal | 57226 |
| Manufacturer Phone | 6058746357 |
| Manufacturer G1 | EMPI, INC. |
| Manufacturer Street | 205 HWY 22 EAST |
| Manufacturer City | CLEAR LAKE SD 57226 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 57226 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HYBRESIS |
| Generic Name | HYBRESIS |
| Product Code | EGJ |
| Date Received | 2011-04-29 |
| Model Number | 199589-001 |
| Lot Number | 83670 |
| Device Expiration Date | 2011-09-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EMPI, INC. |
| Manufacturer Address | 205 HWY 22 EAST CLEAR LAKE SD 57226 US 57226 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-04-29 |