MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-09-23 for ACTION PATCH 199488-001 manufactured by Empi, Inc..
[2196559]
It was reported that when the customer was removing the action patch from the release liner card the patch pulled away from the battery. The patch was not used.
Patient Sequence No: 1, Text Type: D, B5
[9346593]
The reason that pieces of the electrode assembly were coming apart upon attempted removal is that the electrode will not easily release from the (b)(4) coated side. The electrode was placed on the incorrect side of the release liner. This is a consequence of an operator error during manufacturing. The clinic did not use the electrode. "this mdr is being reported because in some situations such as a malfunction could contribute to a serious injury if it were to recur. "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1721293-2011-00009 |
| MDR Report Key | 2261257 |
| Report Source | 06 |
| Date Received | 2011-09-23 |
| Date of Report | 2011-09-15 |
| Date of Event | 2011-08-23 |
| Date Mfgr Received | 2011-08-23 |
| Date Added to Maude | 2012-06-27 |
| 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 | 3 |
| Health Professional | 0 |
| 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 | 6058476357 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACTION PATCH |
| Generic Name | ACTION PATCH |
| Product Code | EGJ |
| Date Received | 2011-09-23 |
| Returned To Mfg | 2011-08-30 |
| Model Number | 199488-001 |
| Device Availability | R |
| 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 | 2011-09-23 |