MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-11 for MEDLINE MEDGEL ECG ELECTRODE RADIOTRANSLUCENT FOAM manufactured by Medline Industries, Inc..
[120137336]
Pt was having an mri scan of spine, monitoring patches with lead wires were left on the pt inadvertently. Pt was in spine precautions and had a back brace, the wires and leads were missed. The pt had 2 blisters under the patches the following day. I do not have a lot number, we are not sure if these were placed at our hosp, or the hosp the pt was transferred in from. This was a trauma.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5079733 |
| MDR Report Key | 7869008 |
| Date Received | 2018-09-11 |
| Date of Report | 2018-09-10 |
| Date of Event | 2018-09-05 |
| Date Added to Maude | 2018-09-12 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | MEDLINE MEDGEL ECG ELECTRODE RADIOTRANSLUCENT FOAM |
| Generic Name | ECG PATCHES, ELECTROSURGICAL ELECTRODE KIT |
| Product Code | JOS |
| Date Received | 2018-09-11 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | MUNDELEIN IL US |
| Brand Name | MEDLINE MEDGEL ECG ELECTRODE RADIOTRANSLUCENT FOAM |
| Generic Name | ECG PATCHES, ELECTROSURGICAL ELECTRODE KIT |
| Product Code | JOS |
| Date Received | 2018-09-11 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE |
| Manufacturer Address | MUNDELEIN IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-09-11 |