MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2012-03-28 for TEN20 CONDUCTIVE PASTE UNK manufactured by D.o. Weaver And Company.
[2575994]
(b)(4).
Patient Sequence No: 1, Text Type: D, B5
[9949512]
(b)(4). We will contact the reporter listed on that form for additional information on the complaint, as well as the current status of the pt. We will submit a follow-up report to the fda at the time of response from the reporter. At this time, we have not been contacted directly by the user facility or the pt.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1718791-2012-00004 |
| MDR Report Key | 2517718 |
| Report Source | 00 |
| Date Received | 2012-03-28 |
| Date Mfgr Received | 2012-03-05 |
| Date Added to Maude | 2012-04-06 |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | NICHOLAS LEE |
| Manufacturer Street | 565 NUCLA WAY, UNIT B |
| Manufacturer City | AURORA CO 80011 |
| Manufacturer Country | US |
| Manufacturer Postal | 80011 |
| Manufacturer Phone | 3033661804 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TEN20 CONDUCTIVE PASTE |
| Generic Name | TEN20 PASTE |
| Product Code | GYB |
| Date Received | 2012-03-28 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | D.O. WEAVER AND COMPANY |
| Manufacturer Address | AURORA CO US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-03-28 |