MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-26 for TEN20 PASTE manufactured by D.o. Weaver And Company.
[46468507]
Have had several patients with continuous eeg monitoring who after removal of eeg monitoring had reddened areas and/or sores to the eeg sites. We purchased all new electrodes, retrained all staff in application and competency of cleaning prior, we changes the dressings we were using and continued to have issues. We reached out to the mfr of the past, weaver company who informed us that the ten20 conductive paste we were using had changed their calcium carbonate formula and that lots 184 to 274 were all affected and should be returned.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5062558 |
| MDR Report Key | 5690769 |
| Date Received | 2016-05-26 |
| Date of Report | 2016-05-26 |
| Date of Event | 2016-03-03 |
| Date Added to Maude | 2016-06-01 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | TEN20 PASTE |
| Generic Name | TEN20 PASTE |
| Product Code | GYB |
| Date Received | 2016-05-26 |
| Returned To Mfg | 2016-03-25 |
| Lot Number | 184-274 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | D.O. WEAVER AND COMPANY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-05-26 |