MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2019-11-19 for SIGNAGEL 15-25 manufactured by Parker Laboratories, Inc.
| Report Number | 2212018-2019-00001 |
| MDR Report Key | 9342304 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2019-11-19 |
| Date of Report | 2019-10-04 |
| Date of Event | 2019-09-28 |
| Date Mfgr Received | 2019-10-04 |
| Date Added to Maude | 2019-11-19 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CANDY BECK |
| Manufacturer Street | 286 ELDRIDGE ROAD |
| Manufacturer City | FAIRFIELD NJ 070047261 |
| Manufacturer Country | US |
| Manufacturer Postal | 070047261 |
| Manufacturer Phone | 9732769500 |
| Manufacturer G1 | PARKER LABORATORIES, INC |
| Manufacturer Street | 286 ELDRIDGE ROAD |
| Manufacturer City | FAIRFIELD NJ 070047261 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 070047261 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SIGNAGEL |
| Generic Name | ELECTRODE GEL |
| Product Code | GYB |
| Date Received | 2019-11-19 |
| Model Number | 15-25 |
| Catalog Number | 15-25 |
| Lot Number | UNKNOWN |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PARKER LABORATORIES, INC |
| Manufacturer Address | 286 ELDRIDGE ROAD FAIRFIELD NJ 070047261 US 070047261 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-11-19 |