MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-03-25 for PRONTOSAN? 400517 manufactured by B.braun Medical Ag.
| Report Number | 3007120504-2020-00001 |
| MDR Report Key | 9880146 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-02-22 |
| Date Mfgr Received | 2020-02-27 |
| Date Added to Maude | 2020-03-25 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JONATHAN SEVERINO |
| Manufacturer Street | 861 MARCON BOULEVARD |
| Manufacturer City | ALLENTOWN, PA |
| Manufacturer Country | US |
| Manufacturer Phone | 2408332 |
| Manufacturer G1 | B.BRAUN MEDICAL AG |
| Manufacturer Street | SEESATZ 17 |
| Manufacturer City | SEMPACH, 6204 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 6204 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRONTOSAN? |
| Generic Name | DRESSING, WOUND, DRUG |
| Product Code | FRO |
| Date Received | 2020-03-25 |
| Returned To Mfg | 2020-03-03 |
| Catalog Number | 400517 |
| Lot Number | 19121M10 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | B.BRAUN MEDICAL AG |
| Manufacturer Address | SEESATZ 17 SEMPACH 6204 SZ 6204 |
| Brand Name | VERIFORTE |
| Product Code | --- |
| Date Received | 2020-03-25 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Manufacturer | FOCUSMED |
| Brand Name | FLAMINAL FORTE |
| Product Code | --- |
| Date Received | 2020-03-25 |
| Device Sequence No | 102 |
| Device Event Key | 0 |
| Manufacturer | PUBLILOC |
| Brand Name | PROMANUM PURE |
| Product Code | --- |
| Date Received | 2020-03-25 |
| Device Sequence No | 103 |
| Device Event Key | 0 |
| Manufacturer | B BRAUN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2020-03-25 |