MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-29 for IN CHECK DIAL L-3122069 manufactured by Alliance Tech Medical, Inc..
[39682361]
Subject participating in clinical trial (b)(4). During visit, subject was to complete pifr test per protocol. When subject took inhalation breath with device in mouth, circular valve on attachment became detached and was sucked into subject's throat. Subject was unable to cough to bring piece out of mouth. Manufacturer aware. Reason for use: testing for clinical study. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5060673 |
| MDR Report Key | 5476513 |
| Date Received | 2016-02-29 |
| Date of Report | 2016-02-28 |
| Date of Event | 2016-02-24 |
| Date Added to Maude | 2016-03-03 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| 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 | IN CHECK DIAL |
| Generic Name | IN CHECK DIAL |
| Product Code | BYP |
| Date Received | 2016-02-29 |
| Model Number | L-3122069 |
| Catalog Number | L-3122069 |
| Lot Number | 79058 |
| ID Number | REV. 01 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | ALLIANCE TECH MEDICAL, INC. |
| Manufacturer Address | PO BOX 6024 GRANBURY TX 76049 US 76049 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-02-29 |