MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2015-09-11 for STETH, BOWLES, BK SES05ABK manufactured by Honsun Nantong Company Ltd..
[25623622]
(b)(4). The device history record could not be reviewed as a lot number was not provided. Multiple attempts to obtain samples from the customer were made and no sample has been received. Review of current production records did not indicate any exception that could lead to the reported incident. A review of the ear tip design demonstrated that the ear bud was secured firmly to the stethoscope and would not fall off accidentally based on the following: the ear tip inner diameter dimension is 4+/-0. 05mm, the binaural od dimension is 4. 9+0. 05mm, providing a tight interface between the ear tip and binaural. Test conducted on the assembly indicated a 3. 0~4. 0kgf force was needed to pull the ear tip off from binaural. It is unlikely that the ear tip would drop off without intentional removal effort. A review of the assembly process was conducted and confirmed to be in control. No records of improper assembly were identify during the investigation. Without the return of the complaint sample for further investigation, the root cause of the missing ear bud could not be determined in this investigation. No additional action will be taken at this time. We will continue to monitor for this type of incident. F
Patient Sequence No: 1, Text Type: N, H10
[25623623]
Customer reported that the rubber ear bud had fallen off the stethoscope and the nurse did not realize it was missing. He (the nurse) placed the stethoscope in his ears and the side without the ear bud went all the way in his ear and pierced his ear drum. Multiple attempts to obtain further patient information have been made but hospital states they are unable to provide.
Patient Sequence No: 1, Text Type: D, B5
[34031288]
(b)(4). The actual sample was returned for investigation on sep 22, 2015. The device history record review did not indicate any exception that could lead to the reported incident. Inspection conducted indicated one missing ear tip but no abnormality was observed. Tension force test on the side with the ear tip indicated an acceptable force of 3. 15kgf. From the investigation, the root cause of the missing ear bud could not be determined. No additional action will be taken at this time. We will continue to monitor for this type of event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423537-2015-00062 |
| MDR Report Key | 5070815 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2015-09-11 |
| Date of Report | 2015-09-11 |
| Date of Event | 2015-08-13 |
| Date Facility Aware | 2015-08-14 |
| Date Mfgr Received | 2015-08-13 |
| Date Added to Maude | 2015-09-11 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MICHELE DONATICH |
| Manufacturer Street | 1500 WAUKEGAN ROAD |
| Manufacturer City | WAUKEGAN IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8478876412 |
| Manufacturer G1 | HONSUN NANTONG COMPANY LTD. |
| Manufacturer Street | NO.8 TONGXING ROAD ECONOMIC&TECHNICAL DEVELOPMENT |
| Manufacturer City | NANTONG CITY |
| Manufacturer Country | CH |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STETH, BOWLES, BK |
| Generic Name | STETH, BOWLES, BK |
| Product Code | LDE |
| Date Received | 2015-09-11 |
| Model Number | SES05ABK |
| Catalog Number | SES05ABK |
| Lot Number | NO LOT GIVEN |
| Operator | NURSE |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HONSUN NANTONG COMPANY LTD. |
| Manufacturer Address | NO.8 TONGXING ROAD ECONOMIC&TECHNICAL DEVELOPMENT NANTONG CITY CH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-09-11 |