MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-15 for ECG ELECTRODES NEONATAL 1.5MM RADIOTRANSLUCENT MDS61115R manufactured by Medline Industries, Inc..
[59936286]
Patient Sequence No: 1, Text Type: N, H10
[59936287]
A new package of ecg electrodes with a broken white lead. The wire was apart from the adhesive for the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6102958 |
| MDR Report Key | 6102958 |
| Date Received | 2016-11-15 |
| Date of Report | 2016-08-30 |
| Date of Event | 2016-07-27 |
| Report Date | 2016-08-30 |
| Date Reported to FDA | 2016-08-30 |
| Date Reported to Mfgr | 2016-08-30 |
| Date Added to Maude | 2016-11-15 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ECG ELECTRODES NEONATAL 1.5MM RADIOTRANSLUCENT |
| Generic Name | MEDLINE ELECTROSURGICAL ELECTRODE KIT |
| Product Code | NWI |
| Date Received | 2016-11-15 |
| Catalog Number | MDS61115R |
| Lot Number | 160220 |
| ID Number | 10884389114872 |
| Device Expiration Date | 2019-02-28 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | ONE MEDLINE PL. MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-15 |