MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07,08 report with the FDA on 2015-02-06 for MAD NASAL WITHOUT SYRINGE MAD300 manufactured by Teleflex Medical.
[15963792]
The complaint is reported as: fluid was leaking from the device because the tip was cracked. Another device was used. This occurred prior to use on a patient. The condition of the patient is unknown.
Patient Sequence No: 1, Text Type: D, B5
[16216696]
(b)(4). The investigation was not complete at the time of this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1722554-2015-00002 |
| MDR Report Key | 4494178 |
| Report Source | 07,08 |
| Date Received | 2015-02-06 |
| Date of Report | 2015-01-20 |
| Date of Event | 2015-01-07 |
| Date Mfgr Received | 2015-01-20 |
| Date Added to Maude | 2015-03-11 |
| 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 | 0 |
| Event Location | 0 |
| 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 | 79 WEST 4500 SOUTH, 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 | NASAL ATOMIZER |
| Product Code | CCT |
| Date Received | 2015-02-06 |
| Catalog Number | MAD300 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-02-06 |