MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-09-28 for ECONO-PASTE manufactured by Hartman.
[16539302]
Product econo-paste unna boot indicated for wound care dressing growing mold inside sealed package. Mold found growing on multiple dressing in specific lot number. No-visible or known - molded dressings were utilized for patient care.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5022613 |
| MDR Report Key | 2296539 |
| Date Received | 2011-09-28 |
| Date of Report | 2011-09-28 |
| Date of Event | 2011-08-24 |
| Date Added to Maude | 2011-10-17 |
| 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 | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | ECONO-PASTE |
| Generic Name | UNNA BOOT |
| Product Code | MGQ |
| Date Received | 2011-09-28 |
| Lot Number | 1104233 |
| Device Expiration Date | 2014-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HARTMAN |
| Manufacturer Address | ROCK HILL SC US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-09-28 |