MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-31 for WOLFETORY MADOMIZER MUCOSAL ATOMIZATION DEVICE MAD500 manufactured by Teleflex Medical.
[134997444]
Concomitant medical products: 3898360-2019-00104, qn# (b)(4). The device involved has not been received by the manufacturer for evaluation at the time of this report. P/n mad500 is not being manufactured currently, however, another part number from the same family was use for the "verification of failure mode reported in the current manufacturing process" and was conducted as follows: 80 samples were taken from the current production p/n mad300 madomizer mucosal atomization device, lot # 73a1900512, the samples were functionally inspected and issue reported as " unit is clogged during use" was not observed in the current manufacturing process. A device history record review could not be conducted since the lot number was not provided. Customer complaint cannot be confirmed at this time. Root cause cannot be determined. If the device sample becomes available, this report will be updated.
Patient Sequence No: 1, Text Type: N, H10
[134997605]
Customer complaint alleges the device became clogged during patient use. No patient injury or consequence was reported. Patient condition reported as fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003898360-2019-00103 |
| MDR Report Key | 8292386 |
| Date Received | 2019-01-31 |
| Date of Report | 2019-01-18 |
| Date of Event | 2019-01-16 |
| Date Mfgr Received | 2019-01-18 |
| Date Added to Maude | 2019-01-31 |
| 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 | LINDA WOODALL |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9196942566 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | RANCHO EL DESCANSO |
| Manufacturer City | TECATE 21478 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 21478 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | WOLFETORY MADOMIZER MUCOSAL ATOMIZATION DEVICE |
| Generic Name | NEBULIZER, MEDICINAL, NON-VENT |
| Product Code | CCQ |
| Date Received | 2019-01-31 |
| Catalog Number | MAD500 |
| Lot Number | UNKNOWN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-31 |