MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2018-08-06 for HUDSON VOLDYNE2500 VOLUMETRIC EXERCISER 8884719025 manufactured by Teleflex Medical.
[116122201]
(b)(4). The device involved in this complaint has not bee received by the manufacturer for evaluation at the time of this report. A device history record investigation did not show issues related to this complaint. Customer complaint cannot be confirmed due the product sample is not available to perform a proper investigation and determine the root cause. Corrective actions cannot be established at this time. If the device sample becomes available at a later date, this report will be updated accordingly.
Patient Sequence No: 1, Text Type: N, H10
[116122202]
Customer complaint alleges the yellow indicator peg sticks during use. Reported by a home care user. Customer states the device must be shaken to reset the peg. No harm was reported. Patient condition reported as "fine".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003898360-2018-00623 |
| MDR Report Key | 7753134 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2018-08-06 |
| Date of Report | 2018-07-20 |
| Date of Event | 2018-07-20 |
| Date Mfgr Received | 2018-07-20 |
| Device Manufacturer Date | 2017-11-14 |
| Date Added to Maude | 2018-08-06 |
| 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 VOLDYNE2500 VOLUMETRIC EXERCISER |
| Generic Name | SPIROMETER, THERAPEUTIC (INCEN |
| Product Code | BWF |
| Date Received | 2018-08-06 |
| Catalog Number | 8884719025 |
| Lot Number | 73L1700257 |
| Operator | LAY USER/PATIENT |
| 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 | 2018-08-06 |