MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-24 for PREMIER PRO 6380 STETHOSCOPE manufactured by Imediplus Inc..
[68298375]
A user of the premier pro 6380 stethoscope suffered a scratched ear when using the device. It was reported that the ear pieces (tips) on the ear tube became loose and allowed ends of the tube to scratch the ear. It was reported to s2s global that the user went to the injury clinic and the clinic confirmed an ear abrasion. There was no report of damage to the ear drum. S2s global followed up with the account that reported the incident on (b)(6) 2016 and on december 20, 2016 (b)(6) responded that the patient had fully recovered and that there was no further examination of the patient other than the initial assessment. We are not able to confirm the user suffering a punctured ear drum.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007304336-2017-00001 |
| MDR Report Key | 6358186 |
| Date Received | 2017-02-24 |
| Date of Report | 2017-02-17 |
| Date of Event | 2016-11-04 |
| Date Facility Aware | 2016-11-04 |
| Report Date | 2016-11-07 |
| Date Reported to FDA | 2016-11-07 |
| Date Reported to Mfgr | 2016-11-11 |
| Date Added to Maude | 2017-02-24 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | RISK MANAGER |
| 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 | 3 |
| Brand Name | PREMIER PRO 6380 STETHOSCOPE |
| Generic Name | STETHOSCOPE |
| Product Code | LDE |
| Date Received | 2017-02-24 |
| Model Number | 6380 |
| Catalog Number | 6380 |
| Lot Number | CASF 07-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 4 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IMEDIPLUS INC. |
| Manufacturer Address | 2F, 12, SHENGTI RD. SEC.2, CHUPEI CITY, HSINCHU COUNTY 302 TW |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-02-24 |