MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-25 for SIEMANS MOTION HEARING AID MOTION SA 3BX 10828750 manufactured by Sivantos Gmbh.
[25126978]
(b)(4) hearing aid dispenser incorrectly dispensed a siemens brand motion sa 3bx hearing aid to a patient under 3 years old in contradiction to the labeling that indicates the hearing aid is not suitable for children younger than 3 years old. Labeling in (b)(4) as well as u. S. Clearly indicates hearing aid is not suitable for children younger than 3 years old. Dispenser was notified that the motion sa 3bx is not suitable for children under 36 months and instructed where this is indicated in the labeling.
Patient Sequence No: 1, Text Type: N, H10
[25126979]
(b)(4) hearing aid dispenser incorrectly dispensed a siemens brand motion sa 3bx hearing aid to a patient under 3 years old, in contradiction to the labeling that indicates the hearing aid is not suitable for children younger than 3 years old. The teething (b)(6) month old (b)(6) patient was fit with the hearing aid on (b)(6) 2015. Earhook broke on (b)(6) 2015 for the first time. Earhook broke for the second time on (b)(6) 2015. Earhook broke for the third time over the weekend between (b)(6) 2015. In each instance the earhook broke at home. The patient swallowed the earhook on the third incident. No medical intervention was necessary as the earhook was excreted naturally by the patient. No damage to the patient's health. Patient no longer wears hearing aid.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005019184-2015-00001 |
| MDR Report Key | 5044889 |
| Date Received | 2015-08-25 |
| Date of Report | 2015-08-24 |
| Date of Event | 2015-07-17 |
| Date Mfgr Received | 2015-07-29 |
| Date Added to Maude | 2015-09-01 |
| 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 | MR. JOHN SCHIRADO |
| Manufacturer Street | 10 CONSTITUTION AVE. |
| Manufacturer City | PISCATAWAY NJ 088540000 |
| Manufacturer Country | US |
| Manufacturer Postal | 088540000 |
| Manufacturer Phone | 7632684605 |
| Manufacturer G1 | SIVANTOS PTE LTD. |
| Manufacturer Street | 20 BLK. AYER RAJAH RESCENT #06-08 |
| Manufacturer City | SINGAPORE 139959 |
| Manufacturer Country | SN |
| Manufacturer Postal Code | 139959 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SIEMANS MOTION HEARING AID |
| Generic Name | BEHIND THE EAR HEARING AID |
| Product Code | OSM |
| Date Received | 2015-08-25 |
| Model Number | MOTION SA 3BX |
| Catalog Number | 10828750 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIVANTOS GMBH |
| Manufacturer Address | HENRIDUNANTSTR. 100 ERLANGEN GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-08-25 |