MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-30 for EXOFIN FUSION manufactured by Chemence Medical Inc..
[164843400]
Product flaking off and rolling up.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5090803 |
| MDR Report Key | 9260788 |
| Date Received | 2019-10-30 |
| Date of Report | 2019-10-28 |
| Date Added to Maude | 2019-10-31 |
| 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 |
| 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 | 0 |
| Brand Name | EXOFIN FUSION |
| Generic Name | CUTANEOUS TISSUE ADHESIVE WITH MESH |
| Product Code | OMD |
| Date Received | 2019-10-30 |
| Returned To Mfg | 2019-10-28 |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CHEMENCE MEDICAL INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-10-30 |