MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-10 for CAVN STETHOSCOPE SC133 NO CAT NUMBER manufactured by Cavn.
[174895488]
Bought cavn brand stethoscope from (b)(6), the products claim latex free on advertising picture. I used 2 weeks and it got my skin of neck latex allergy. In addition, the cavn stethoscope does not have fda device listing and mfr registration. I believe they market their products illegally and fail to meet fda requirements; because no lot number, mfr info, distributor info, and exp date on product packaging and product itself. Product listing linkage: (b)(6). Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092193 |
| MDR Report Key | 9581818 |
| Date Received | 2020-01-10 |
| Date of Report | 2020-01-08 |
| Date of Event | 2020-01-07 |
| Date Added to Maude | 2020-01-13 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | PATIENT |
| 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 | CAVN STETHOSCOPE |
| Generic Name | STETHOSCOPE, MANUAL |
| Product Code | LDE |
| Date Received | 2020-01-10 |
| Model Number | SC133 |
| Catalog Number | NO CAT NUMBER |
| Lot Number | NO LOT NUMBER |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAVN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2020-01-10 |