MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-30 for REGARD DEFIBRILLATOR PAD manufactured by Resource Optimization & Innovation, L.l.c..
[125483259]
Patient received from operating room with defibrillator pads attached to his back. Removal of the pad on his right scapula revealed a skin tear under the lower edge of the pad. Skin tear under defibrillator pad. Patient was transferred from operating room to cardiovascular recovery room at approximately 1325. Per registered nurse, upon removing the defibrillator pads, it was noted that the patient had a small skin tear to the right scapular area. A foam mepilex dressing was applied to the wound. Supply chain met with defib pad vendor and also presented additional product removal technique to department manager. Alternate product brought in temporarily until additional team member education can be completed. No other departments have reported this issue with pad use; pads used in incident not kept to complete quality check or review lot # specific issue. Device not available to return.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8018516 |
| MDR Report Key | 8018516 |
| Date Received | 2018-10-30 |
| Date of Report | 2018-10-25 |
| Date of Event | 2018-06-14 |
| Report Date | 2018-10-25 |
| Date Reported to FDA | 2018-10-25 |
| Date Reported to Mfgr | 2018-10-30 |
| Date Added to Maude | 2018-10-30 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| 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 | 3 |
| Brand Name | REGARD DEFIBRILLATOR PAD |
| Generic Name | ELECTRODE, ELECTRODCARDIOGRAPH, MULTI-FUNCTION |
| Product Code | MLN |
| Date Received | 2018-10-30 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | RESOURCE OPTIMIZATION & INNOVATION, L.L.C. |
| Manufacturer Address | 3000 E SAWYER RD REPUBLIC MO 65738 US 65738 |
| Brand Name | REGARD DEFIBRILLATOR PAD |
| Generic Name | ELECTRODE, ELECTRODCARDIOGRAPH, MULTI-FUNCTION |
| Product Code | OEV |
| Date Received | 2018-10-30 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RESOURCE OPTIMIZATION & INNOVATION, L.L.C. |
| Manufacturer Address | 3000 E SAWYER RD REPUBLIC MO 65738 US 65738 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-10-30 |