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.
[5331762]
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 patient. The condition of the patient is unknown.
Patient Sequence No: 1, Text Type: D, B5
[12905474]
(b)(4). The device was returned, however, the investigation was not complete at the time of this report. A follow-up report will be submitted with investigation results.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1722554-2015-00001 |
| MDR Report Key | 4494173 |
| Report Source | 07,08 |
| Date Received | 2015-02-06 |
| Date of Report | 2015-01-20 |
| Date of Event | 2014-12-16 |
| 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 |
| Returned To Mfg | 2015-01-29 |
| Catalog Number | MAD300 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 |