MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-09-25 for ALDAHOL manufactured by Dfb Technology, Ltd..
| Report Number | 3003690398-2019-00003 |
| MDR Report Key | 9121493 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-09-25 |
| Date of Report | 2019-09-25 |
| Date of Event | 2019-07-29 |
| Date Mfgr Received | 2019-08-05 |
| Device Manufacturer Date | 2019-04-01 |
| Date Added to Maude | 2019-09-25 |
| 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. MARK MITCHELL |
| Manufacturer Street | 3909 HULEN ST |
| Manufacturer City | FORT WORTH TX 76107 |
| Manufacturer Country | US |
| Manufacturer Postal | 76107 |
| Manufacturer Phone | 8179004074 |
| Manufacturer G1 | ALDEN MEDICAL LLC |
| Manufacturer Street | 360 COLD SPRING AVENUE |
| Manufacturer City | WEST SPRINGFIELD MA 01089 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01089 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALDAHOL |
| Generic Name | HIGH LEVEL DISINFECTANT |
| Product Code | MED |
| Date Received | 2019-09-25 |
| Lot Number | 191947 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DFB TECHNOLOGY, LTD. |
| Manufacturer Address | 3909 HULEN ST FORT WORTH 76107 US 76107 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-09-25 |