MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-23 for 3M? LITTMAN? CLASSIC? III STETHOSCOPE 5622 manufactured by 3m Health Care.
[133937335]
No information was provided. Device was not returned for evaluation. End of report.
Patient Sequence No: 1, Text Type: N, H10
[133937336]
A female alleged two ear infections on separate occasions and a rash on the neck. Use of a 3m? Littman? Classic? Iii monitoring stethoscope began in (b)(6) 2018. She was seen in urgent care and in the emergency room on separate occasions and was treated with prescription antibiotics, an oral steroid and ear drops. The rash resolved and the most recent ear infection is resolving.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2019-00009 |
| MDR Report Key | 8272573 |
| Date Received | 2019-01-23 |
| Date of Report | 2019-01-23 |
| Date of Event | 2018-10-31 |
| Date Mfgr Received | 2019-01-02 |
| Date Added to Maude | 2019-01-23 |
| 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 | MS. DIANNE GIBBS |
| Manufacturer Street | 3M CENTER, BUILDING 275-5W-06 2510 CONWAY AVE |
| Manufacturer City | ST. PAUL MN 55144 |
| Manufacturer Country | US |
| Manufacturer Postal | 55144 |
| Manufacturer Phone | 6517379117 |
| Manufacturer G1 | 3M HEALTH CARE |
| Manufacturer Street | 5400 ROUTE B |
| Manufacturer City | COLUMBIA MO 652029348 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 652029348 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | 3M? LITTMAN? CLASSIC? III STETHOSCOPE |
| Generic Name | MANUAL STETHOSCOPE |
| Product Code | LDE |
| Date Received | 2019-01-23 |
| Catalog Number | 5622 |
| Lot Number | 201711CD |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M HEALTH CARE |
| Manufacturer Address | 2510 CONWAY AVE ST. PAUL MN 55144 US 55144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-01-23 |