MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-04-30 for PRIMAPORE DRESSING 4" X 3&1/8" manufactured by .
[2753592]
Rash under dressing, call summary: pt called to report she now has a rash under her dressing. States it has itched for a while, but now a red rash. No swelling, drainage, advised pt to cleanse area with dressing kit, allowing each step to dry before moving to next step. Then to use only a sterile 4x4 gauze dressing taped on, for 2-3 days. She agreed. Advised she will need to monitor this dressing and change it immediately if gets moist or damp. She voiced understanding. Agreed to call back 24/7 if rash worsens, does not improve, any drainage, swelling, etc. Will request branch staff follow up. Did not specify which dressing is causing the issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5025283 |
| MDR Report Key | 2561670 |
| Date Received | 2012-04-30 |
| Date of Report | 2012-04-18 |
| Date of Event | 2012-04-17 |
| Date Added to Maude | 2012-05-08 |
| 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 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| 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 | PRIMAPORE DRESSING 4" X 3&1/8" |
| Generic Name | DRESSINGS |
| Product Code | KGX |
| Date Received | 2012-04-30 |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Brand Name | DRESSING CHANGE KIT W/CHLORHEXIDINE |
| Generic Name | DRESSING CHANGE KIT |
| Product Code | MCY |
| Date Received | 2012-04-30 |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-04-30 |