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 2016-08-19 for HUDSON TRIFLO II INCENTIVE DEEP BREATHING EXER 8884717301 manufactured by Teleflex Medical.
[52513616]
(b)(4). The device sample is received by the manufacturer, but the investigation is not complete at this time. A device history record investigation was conducted and did not show issues related to complaint. A document assessment (fmea) was conducted and no changes required.
Patient Sequence No: 1, Text Type: N, H10
[52513617]
The customer alleges an air leak from the device.
Patient Sequence No: 1, Text Type: D, B5
[55600130]
(b)(4). The sample was returned for evaluation. A visual exam was performed and no defects were observed. Functional testing was also performed and no leaks were detected. The reported complaint of an air leakage from the product was not confirmed based upon the sample received. The returned breathing exerciser was able to pass a functional inspection when connected to vacuumed air. A dhr review was performed on the lot number with no evidence to suggest a manufacturing related cause. There were no functional issues found with the returned sample. No further action will be taken.
Patient Sequence No: 1, Text Type: N, H10
[55600131]
The customer alleges an air leak from the device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003898360-2016-00780 |
| MDR Report Key | 5888665 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-08-19 |
| Date of Report | 2016-07-27 |
| Date of Event | 2016-07-25 |
| Date Mfgr Received | 2016-09-21 |
| Device Manufacturer Date | 2015-06-09 |
| Date Added to Maude | 2016-08-19 |
| 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 | KATHARINE TARPLEY |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194334854 |
| 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 | INCENTIVE SPIROMETER |
| Product Code | BWF |
| Date Received | 2016-08-19 |
| Returned To Mfg | 2016-08-12 |
| Catalog Number | 8884717301 |
| Lot Number | 73F1500194 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-08-19 |