MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-11-13 for ULTRASORB AP UNDERPAD * UNKNOWN manufactured by Medline Industries, Inc.
[5298682]
A medline ultrasorb underpad being used under a burn patient turned blue, appeared to be wicking the blue chemical from the pad into and through the dressings. This reaction was replicated using a clean dressing, clean pad and the sulfamylon. Another type of pad was then used, and the patient did not appear to be harmed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4283257 |
| MDR Report Key | 4283257 |
| Date Received | 2014-11-13 |
| Date of Report | 2014-11-13 |
| Date of Event | 2014-10-19 |
| Report Date | 2014-11-13 |
| Date Reported to FDA | 2014-11-13 |
| Date Reported to Mfgr | 2014-11-28 |
| Date Added to Maude | 2014-11-28 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTRASORB AP UNDERPAD |
| Generic Name | BODY FLUID BARRIER |
| Product Code | LWG |
| Date Received | 2014-11-13 |
| Model Number | * |
| Catalog Number | UNKNOWN |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Device Age | 1 DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC |
| Manufacturer Address | ONE MEDLINE PLACE MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-11-13 |