MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-16 for MAD NASAL WITHOUT SYRINGE MAD300 manufactured by Wolfe Tory Medical Inc..
[65357712]
(b)(4) the device involved in this complaint has been returned to the manufacturer. However, the investigation into said device is still in progress at the time of this report.
Patient Sequence No: 1, Text Type: N, H10
[65357715]
Customer complaint alleges that "the mad300 packaging was missing the variable lot printing". Alleged issue was detected during incoming inspection, prior to patient involvement.
Patient Sequence No: 1, Text Type: D, B5
[69125349]
(b)(4). The sample was not returned for evaluation; however, the customer returned a photo. The photo confirmed that the pouch has incomplete printing. A device history record (dhr) review was performed and there were no issues found that could relate to the reported complaint. Based on the investigation performed, the reported complaint was confirmed. The product was placed on ship hold and a capa was opened to address this issue.
Patient Sequence No: 1, Text Type: N, H10
[69125350]
Customer complaint alleges that "the mad300 packaging was missing the variable lot printing". Alleged issue was detected during incoming inspection, prior to patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722554-2017-00001 |
| MDR Report Key | 6253794 |
| Date Received | 2017-01-16 |
| Date of Report | 2016-12-20 |
| Date of Event | 2016-12-20 |
| Date Mfgr Received | 2017-02-22 |
| Date Added to Maude | 2017-01-16 |
| 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 | KATHARINE TARPLEY |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194334854 |
| Manufacturer G1 | WOLFE TORY MEDICAL INC. |
| Manufacturer Street | 79W 4500 S SUITE 18 |
| Manufacturer City | SALT LAKE CITY UT 84107 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 84107 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAD NASAL WITHOUT SYRINGE |
| Generic Name | MUCOSAL ATOMIZATION DEVICE |
| Product Code | CCQ |
| Date Received | 2017-01-16 |
| Returned To Mfg | 2017-01-05 |
| Catalog Number | MAD300 |
| Lot Number | 160518 |
| Device Expiration Date | 2019-05-12 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WOLFE TORY MEDICAL INC. |
| Manufacturer Address | SALT LAKE CITY UT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-16 |