MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2017-04-19 for VPEP manufactured by D R Burton Healthcare, Llc.
[73223612]
Reference # mw5067507 and (b)(4). As a response to the mdr report number mw5067507, d r burton healthcare, llc performed an investigation into the claims made and provides the following manufacturer update: to date d r burton has had no direct complaints from any customers, there was no healthcare professional information provided to pursue the basis of this claim, no product was returned, and post market surveillance; we contacted 100% of our customers and 0% reported any problems with this reported issue or any other product concerns.
Patient Sequence No: 1, Text Type: N, H10
[73223613]
Reference #: mw5067507 and (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012970776-2017-00001 |
| MDR Report Key | 6504626 |
| Report Source | OTHER |
| Date Received | 2017-04-19 |
| Date of Report | 2017-01-23 |
| Date Mfgr Received | 2017-02-24 |
| Date Added to Maude | 2017-04-19 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. JANICE JONES |
| Manufacturer Street | 3936 SOUTH FIELDS STREET |
| Manufacturer City | FARMVILLE NC 27828 |
| Manufacturer Country | US |
| Manufacturer Postal | 27828 |
| Manufacturer Phone | 2522287047 |
| Manufacturer G1 | D R BURTON HEALTHCARE, LLC |
| Manufacturer Street | 3936 SOUTH FIELDS STREET |
| Manufacturer City | FARMVILLE NC 27828 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27828 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VPEP |
| Generic Name | OPEP |
| Product Code | BWF |
| Date Received | 2017-04-19 |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | D R BURTON HEALTHCARE, LLC |
| Manufacturer Address | 3936 SOUTH FIELDS STREET FARMVILLE NC 27828 US 27828 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-19 |