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..
[125488966]
Skin alteration noted when patient bathed after coming out of the operating room (or) after surgery. Skin tear to left scapula in a square pattern. Per registered nurse, recognition of skin integrity impairment noted upon patient's transfer from the or. Per wound management note: "patient has an elevated creatinine, anemia, and hyperglycemia which can contribute to poor tissue perfusion and delayed healing, giving the patient a risk for skin breakdown. " since the conversion to the "regard" defibrillator pad in question, a sudden increase in skin tears have been noted. All cases reviewed, education completed by company representative to cardiovascular operating room team members and appropriate removal technique reviewed. I would also like to note, this pad is utilized along with a warming blanket, known as the blanketrol, to maintain patient temperature. Discussions with company rep have arose regarding the possibility of increased tackiness to the pad in production, as well as an increase in tackiness due to the blanketrol heat pad being used. Both theories are being reviewed. Regard defibrillator pad. Device is not available for return.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8018517 |
| MDR Report Key | 8018517 |
| Date Received | 2018-10-30 |
| Date of Report | 2018-10-25 |
| Date of Event | 2018-06-29 |
| 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 | 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 |