MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-30 for DERMAFLEX QS LB60406 manufactured by Chemence Medical.
| Report Number | 3010034760-2020-00001 |
| MDR Report Key | 9897353 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-04 |
| Date of Event | 2020-03-04 |
| Date Mfgr Received | 2020-03-04 |
| Device Manufacturer Date | 2019-08-05 |
| Date Added to Maude | 2020-03-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | CHARNELLE THOMAS |
| Manufacturer Street | 200 TECHNOLOGY DR. |
| Manufacturer City | ALPHARETTA, GA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DERMAFLEX QS |
| Generic Name | TISSUE ADHESIVE |
| Product Code | MPN |
| Date Received | 2020-03-30 |
| Model Number | LB60406 |
| Lot Number | 0034D |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CHEMENCE MEDICAL |
| Manufacturer Address | 200 TECHNOLOGY DR. ALPHARETTA, GA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-30 |