MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-01-04 for HYBRESIS 199589-001 manufactured by Empi.
[1790187]
It was reported that a pt suffered a burn under the battery area of the hybresis patch. The pt was being treated for s/p nerve transposition, using dexamethasone 1. 5cc, concentration 4mg/ml. The treatment time was 2 hours. The pt did not require any special attention for the burn.
Patient Sequence No: 1, Text Type: D, B5
[8872108]
The patch was received for investigation. The electrode did not meet physical or electrical specification, as the flex circuit was cut. This report is being submitted because empi has received a similar complaint 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 | 1721293-2010-00020 |
| MDR Report Key | 1952443 |
| Report Source | 06 |
| Date Received | 2011-01-04 |
| Date of Report | 2010-12-20 |
| Date of Event | 2010-10-20 |
| Date Mfgr Received | 2010-10-26 |
| Date Added to Maude | 2012-01-25 |
| 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 Contact | DEBBIE MIRANDA |
| Manufacturer Street | 205 HWY 22 EAST |
| Manufacturer City | CLEAR LAKE SD 57226 |
| Manufacturer Country | US |
| Manufacturer Postal | 57226 |
| Manufacturer Phone | 6058746357 |
| 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 | 2011-01-04 |
| Returned To Mfg | 2010-12-13 |
| Model Number | 199589-001 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EMPI |
| Manufacturer Address | 205 HWY 22 EAST CLEAR LAKE SD 57226 US 57226 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-01-04 |