MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-02-22 for HUDSON TRIFLO II INCENTIVE DEEP BREATHING EXER 8884717301 manufactured by Teleflex Medical.
[67939745]
(b)(4). A visual, dimensional, and functional inspection of the device involved in the complaint could not be conducted since the device was not returned. A device history record investigation did not show issues related to complaint. A record assesment (fmea) was conducted and no changes required. Corrective actions cannot be established since it is necessary to receive the physical sample to perform a proper investigation and confirm the alleged defect. Customer complaint cannot be confirmed. If the device sample becomes available at a later date, this complaint will be updated accordingly.
Patient Sequence No: 1, Text Type: N, H10
[67939746]
Customer complaint alleges that "it was reported that even the air flow rate was maximized the ball in the middle cylinder didn't move at all. " alleged malfunction was detected during use. No harm or injury to the patient was reported. Patient condition reported as "fine. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003898360-2017-00099 |
| MDR Report Key | 6348784 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-02-22 |
| Date of Report | 2017-02-01 |
| Date of Event | 2017-01-31 |
| Date Mfgr Received | 2017-02-01 |
| Device Manufacturer Date | 2016-06-21 |
| Date Added to Maude | 2017-02-22 |
| 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 | 3 |
| Brand Name | HUDSON TRIFLO II INCENTIVE DEEP BREATHING EXER |
| Generic Name | SPIROMETER, THERAPUETIC |
| Product Code | BWF |
| Date Received | 2017-02-22 |
| Catalog Number | 8884717301 |
| Lot Number | 73F1600455 |
| Device Availability | N |
| 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 | 2017-02-22 |