MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-06 for MED-DYNE G536L manufactured by Med-dyne, Inc..
[79141204]
Patient Sequence No: 1, Text Type: N, H10
[79141205]
The metal contact leads were loose from the gel pads when the package was opened. This apparently has been an ongoing issue requiring the use of tape to keep the metal contacts in place.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6689059 |
| MDR Report Key | 6689059 |
| Date Received | 2017-07-06 |
| Date of Report | 2017-06-30 |
| Date of Event | 2017-06-12 |
| Report Date | 2017-06-30 |
| Date Reported to FDA | 2017-06-30 |
| Date Reported to Mfgr | 2017-06-30 |
| Date Added to Maude | 2017-07-06 |
| 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 | MED-DYNE |
| Generic Name | CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR) |
| Product Code | DSA |
| Date Received | 2017-07-06 |
| Model Number | G536L |
| Catalog Number | G536L |
| Lot Number | 051731162 |
| Operator | NURSE |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MED-DYNE, INC. |
| Manufacturer Address | 2775 S. FLOYD STREET LOUISVILLE KY 40209 US 40209 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-06 |