MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,08 report with the FDA on 2010-12-11 for ACTION PATCH ELECTRODE 199488-001 manufactured by Empi.
[1686020]
It was reported to empi that a patient was burned using our action patch device. Reasonable attempts were made to obtain further information from the user facility; however, none was provided.
Patient Sequence No: 1, Text Type: D, B5
[8806575]
The suspect device was returned and an evaluation was performed. The device did not meet physical specifications due to the karaya gel missing. The patch was also used past the expiration date of august 2010. If the action patch was used without karaya gel this could cause a burn. If more information becomes available, a follow up report will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1721293-2010-00018 |
| MDR Report Key | 1931903 |
| Report Source | 06,08 |
| Date Received | 2010-12-11 |
| Date of Report | 2010-12-07 |
| Date of Event | 2010-11-05 |
| Date Mfgr Received | 2010-11-05 |
| Device Manufacturer Date | 2009-12-01 |
| Date Added to Maude | 2011-02-04 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | ACTION PATCH ELECTRODE |
| Generic Name | ACTION PATCH |
| Product Code | EGJ |
| Date Received | 2010-12-11 |
| Returned To Mfg | 2010-11-29 |
| Catalog Number | 199488-001 |
| Lot Number | 81060 |
| Device Expiration Date | 2010-08-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2010-12-11 |