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 |