MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-11-25 for KERAMATRIX NDC 71474-303-05 UNK manufactured by Molecular Biologicals, Llc.
[168059363]
New squamous cell cancer noted at site of previous melanoma excision and after use of topical products and graft. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5091281 |
| MDR Report Key | 9376164 |
| Date Received | 2019-11-25 |
| Date of Report | 2019-11-22 |
| Date of Event | 2019-10-09 |
| Date Added to Maude | 2019-11-26 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| 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 | KERAMATRIX |
| Generic Name | DRESSING, WOUND, DRUG |
| Product Code | FRO |
| Date Received | 2019-11-25 |
| Model Number | NDC 71474-303-05 |
| Catalog Number | UNK |
| Lot Number | EXP 122019 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MOLECULAR BIOLOGICALS, LLC |
| Brand Name | KERAGEL |
| Generic Name | DRESSING, WOUND, DRUG |
| Product Code | FRO |
| Date Received | 2019-11-25 |
| Model Number | NDC 71474-303-05 |
| Lot Number | EXP 122019 |
| Device Availability | * |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | MOLECULAR BIOLOGICALS, LLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-11-25 |