MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-29 for PREMIERPRO 6380 manufactured by S2s Global.
[61003239]
Patient Sequence No: 1, Text Type: N, H10
[61003240]
The ear pieces are loose and move very freely up and down the metal shafts along with spinning around the shafts. In one instance, a health care provider suffered a perforated eardrum as a result of the metal shaft penetrating through the ear piece and into her ear canal. Manufacturer response for disposable stethoscope, dual head disposable stethoscope (yellow) (per site reporter): the manufacturer shipped in different lot numbers of older manufacturing dates. Otherwise, dialogue continues between our facility and the manufacturer to determine a root cause of the issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6131483 |
| MDR Report Key | 6131483 |
| Date Received | 2016-11-29 |
| Date of Report | 2016-11-07 |
| Date of Event | 2016-11-04 |
| Report Date | 2016-11-07 |
| Date Reported to FDA | 2016-11-07 |
| Date Reported to Mfgr | 2016-11-07 |
| Date Added to Maude | 2016-11-29 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| 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 | PREMIERPRO |
| Generic Name | STETHOSCOPE, MANUAL |
| Product Code | LDE |
| Date Received | 2016-11-29 |
| Catalog Number | 6380 |
| Lot Number | CASF07-01 |
| ID Number | DUAL HEAD DISPOSABLE STETHOSC |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | S2S GLOBAL |
| Manufacturer Address | 600 JEFFERSON PLAZA, SUITE 202 ROCKVILLE MD 20852 US 20852 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2016-11-29 |