MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-06-30 for GENERIC HOLLISTER ADAPT OSTOMY PASTE manufactured by Hollister.
[18028231]
Here are two products (hollister adapt ostomy paste and ilex skin protectant paste) that i see mixed up in my practice. The results can lead to major skin breakdown. Medication administered to or used by the pt: no. (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5043603 |
| MDR Report Key | 4895224 |
| Date Received | 2015-06-30 |
| Date of Report | 2015-04-23 |
| Date Added to Maude | 2015-07-08 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GENERIC HOLLISTER ADAPT OSTOMY PASTE |
| Generic Name | GENERIC HOLLISTER ADAPT OSTOMY PASTE |
| Product Code | EXE |
| Date Received | 2015-06-30 |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLLISTER |
| Brand Name | GENERIC ILEX SKIN PROTECTANT PASTE |
| Generic Name | GENERIC ILEX SKIN PROTECTANT PASTE |
| Product Code | NEC |
| Date Received | 2015-06-30 |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | ILEX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-06-30 |