MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-12 for BURLINGTON MEDICAL 401 manufactured by Burlington Medical.
| Report Number | 1222742-2019-00003 |
| MDR Report Key | 8693065 |
| Date Received | 2019-06-12 |
| Date of Report | 2019-05-14 |
| Date Mfgr Received | 2019-05-19 |
| Device Manufacturer Date | 2016-11-23 |
| Date Added to Maude | 2019-06-12 |
| 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 | MR. JOHN DASPIT |
| Manufacturer Street | 7 ELMHURST DR |
| Manufacturer City | NEWPORT NEWS VA 23603 |
| Manufacturer Country | US |
| Manufacturer Postal | 23603 |
| Manufacturer Phone | 7579685846 |
| Manufacturer G1 | BURLINGTON MEDICAL |
| Manufacturer Street | 7 ELMHURST ST |
| Manufacturer City | NEWPORT NEWS VA 23603 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 23603 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BURLINGTON MEDICAL |
| Generic Name | LEAD APRON |
| Product Code | EAJ |
| Date Received | 2019-06-12 |
| Model Number | 401 |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BURLINGTON MEDICAL |
| Manufacturer Address | 7 ELMHURST ST. NEWPORT NEWS VA 23603 US 23603 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-06-12 |