MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2018-01-12 for 3M LITTMANN? SELECT STETHOSCOPE 2299 N/A manufactured by 3m Health Care.
[97272956]
No lot number was provided in the complaint. Without lot number it is not possible to determine the expiration nor manufacture date. This is a class i device so udi has not yet been established nor is it required as of the date of this report. This type of reported event is very rare. Initial reporter is awaiting dermatology referral from the (b)(6). The exact date of the event was not stated other than the month of (b)(6) and year 2017 related to the flare up. Therefore, used (b)(6) 2017 as a date since field requires dd. End of report.
Patient Sequence No: 1, Text Type: N, H10
[97272957]
A female reported she was diagnosed with otis externa in both ears. The ear nose throat (ent) professional diagnosed the condition as a class 4 allergic reaction to the stethoscope ear buds or a dermatology issue irritated by having ear buds on sensitive skin area of her ears. She has experienced face swelling, pain, wet and itchy ears. The events have caused her to make three emergency doctor appointments. She has used numerous steroid ear drops and antibiotics (types not specified) for the condition described as otis externa. She has been using a stethoscope since 2007 and has had ongoing issues with her ears since 2011 with a flare up in (b)(6) 2017. She has had some improvement with the use of steroids but the condition has not been completely resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2018-00007 |
| MDR Report Key | 7187452 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2018-01-12 |
| Date of Report | 2018-01-12 |
| Date of Event | 2017-11-01 |
| Date Mfgr Received | 2017-12-14 |
| Date Added to Maude | 2018-01-12 |
| 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. LINDA JOHNSEN |
| 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 | 6517374376 |
| Manufacturer G1 | 3M HEALTH CARE |
| Manufacturer Street | 5400 PARIS ROAD |
| Manufacturer City | COLUMBIA MO 65202 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 65202 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3M LITTMANN? SELECT STETHOSCOPE |
| Generic Name | MANUAL STETHOSCOPE |
| Product Code | LDE |
| Date Received | 2018-01-12 |
| Model Number | 2299 |
| Catalog Number | N/A |
| Lot Number | UNK |
| 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 | 2018-01-12 |