MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-13 for TD-100 manufactured by Unk.
[111305050]
Patient reports that td-100 device shuts off in the middle of his treatments and needs to power it back on in order to finish. Pt has not experienced any ade due to device. Pt does have back up device that is working properly. Pt initially declined offer to ship replacement device. Cnss sent e-mail to the pharmacy that a new device be sent to the patient. Pharmacy is reaching out to patient to schedule shipment of replacement device. Serial number of device in question: (b)(4). No other information known. Dates of use: (b)(6) 2018 to ongoing. Diagnosis or reason for use: pah. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5077859 |
| MDR Report Key | 7600683 |
| Date Received | 2018-06-13 |
| Date of Report | 2018-06-07 |
| Date of Event | 2018-06-07 |
| Date Added to Maude | 2018-06-14 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | TD-100 |
| Generic Name | INHALER, NASAL |
| Product Code | KCO |
| Date Received | 2018-06-13 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-13 |