MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2012-09-27 for HYBRESIS 199589-001 manufactured by Empi, Inc..
[2886142]
It was reported to empi on (b)(6) 2012, that a patient was allegedly burned with a hybresis patch on (b)(6) 2009.
Patient Sequence No: 1, Text Type: D, B5
[10138835]
The suspect device was not returned for empi to evaluate. 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. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1721293-2012-00004 |
| MDR Report Key | 2762477 |
| Report Source | 00 |
| Date Received | 2012-09-27 |
| Date of Report | 2012-06-04 |
| Date of Event | 2009-09-25 |
| Date Mfgr Received | 2012-06-19 |
| Date Added to Maude | 2012-09-27 |
| 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 | 0 |
| Reporter Occupation | ATTORNEY |
| 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 | 6058477057 |
| 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 | 2012-09-27 |
| Model Number | 199589-001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2012-09-27 |