MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2018-09-26 for EC2 CREAM manufactured by Natus Manufacturing Ltd.
[121751594]
Further information was requested from the patient who was the initial reporter of this adverse event. The facility name was provided and natus attempted to contact this facility on numerous occasions through phone for further information (part number / lot number etc. ). No response to any of natus voicemails were received. Justification for not providing below information and applicable sections: relevant tests / laboratory data - the patient was asked this question but did not provide this information. Natus has attempted to contact the facility on numerous occasions but no response has been received. Suspect products - not applicable. Model #, catalog #, lot#, expiration date, unique identifier - defect part number and lot number requested from the patient but this information was not available to the patient. Natus has attempted to contact the facility on numerous occasions but no response has been received. Serial # - this section is not applicable as the medical device does not have a serial number. If implanted date (mm/dd/yyyy) - this section is not applicable as the medical device is not implantable. If explanted date (mm/dd/yyyy) - this section is not applicable as the medical device is not implantable. Reprocessor name and address - this section is not applicable as the medical device is not a single-use device that was reprocessed or reused on a patient. Concomitant medical products and therapy dates (excluding treatment of event) - this section is not applicable to this type of device. Initial reporter - initial reporter in this case was the patient. No information on the patients address. The facility establishment address is as follows: (b)(6). For use by user facility / importer - not applicable as we are not a facility or importer of device. Pms/510(k) - not applicable - pre-amendment. If nd, give protocol # - this section is not applicable as the medical device is not ind. Adverse event terms - this section is not applicable to medical devices. Device manufacture date - unknown device lot number to determine manufacture date if remedial action initiated , check type - this section is not applicable as no remedial action was initiated. If action reported to fda under 21 usc 360i (f), list correction / removal reporting number - this section is not applicable as there was no action reported under 21 usc 360i(f).
Patient Sequence No: 1, Text Type: N, H10
[121751595]
Allergic reaction to ec2 cream. During a 3 day ambulatory eeg, the patient had electrodes placed onto him. The patient felt a throbbing, a bit of an itch and slight pain but was told this was normal. The throbbing was not painful, just a throbbing sensation. Throughout the weekend the patients head itched and he had some slight pain. On removal of the eeg electrodes, it was noticed that there was a serious allergic reaction. Very nasty red spots on the patients forehead and top of the head. The clinic stated that this could only be caused by the glue or paste used during the procedures.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005581270-2018-00012 |
| MDR Report Key | 7910140 |
| Report Source | OTHER |
| Date Received | 2018-09-26 |
| Date of Report | 2018-10-24 |
| Date of Event | 2018-08-13 |
| Date Mfgr Received | 2018-08-28 |
| Date Added to Maude | 2018-09-26 |
| 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 | MISS LOUISE CALLANAN |
| Manufacturer Street | IDA BUSINESS PARK GORT |
| Manufacturer City | GALWAY, CONNAUGHT H91PD92 |
| Manufacturer Country | EI |
| Manufacturer Postal | H91PD92 |
| Manufacturer G1 | NATUS MANUFACTURING LTD |
| Manufacturer Street | IDA BUSINESS PARK GORT |
| Manufacturer City | GALWAY, CONNAUGHT H91PD92 |
| Manufacturer Country | EI |
| Manufacturer Postal Code | H91PD92 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EC2 CREAM |
| Generic Name | EC2? GENUINE GRASS ELECTRODE CREAM |
| Product Code | GYB |
| Date Received | 2018-09-26 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS MANUFACTURING LTD |
| Manufacturer Address | IDA BUSINESS PARK GORT GALWAY, CONNAUGHT H91PD92 EI H91PD92 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-09-26 |