MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-11-12 for 3M LITTMANN ELECTRONIC STETHOSCOPE 3100 NA manufactured by 3m Health Care.
[20270270]
It was reported that a female respiratory therapist, with a severe latex allergy, reported she used a soft black ear tip that she borrowed from her boss after her soft grey ear tip split. Reportedly, she cleaned it with alcohol before using it on her scope. The user used it in a patient's room and her ear became beet red, swollen, started itching and the reaction spread to her head, face, and arm. Reportedly went to the er and was treated with benadryl and decadron (im injection) and a vistaril prescription. User stated her boss is currently using the black ear tip.
Patient Sequence No: 1, Text Type: D, B5
[20478096]
Lot number was not provided. Device does not have an expiration date. Actual used device was not returned. Without lot number, it is not possible to determine the manufacture date. This product is not made with natural rubber latex.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2110898-2013-00071 |
| MDR Report Key | 3535739 |
| Report Source | 05 |
| Date Received | 2013-11-12 |
| Date of Report | 2013-10-24 |
| Date of Event | 2013-10-23 |
| Date Mfgr Received | 2013-10-24 |
| Date Added to Maude | 2014-01-09 |
| 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 |
| Reporter Occupation | RESPIRATORY THERAPIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | LINDA JOHNSEN, REG AFFS SPLST |
| Manufacturer Street | 3M CENTER, BLDG. 275-5W-06 |
| Manufacturer City | ST. PAUL MN 551441000 |
| Manufacturer Country | US |
| Manufacturer Postal | 551441000 |
| Manufacturer Phone | 6517374376 |
| Manufacturer G1 | BENCHMARK ELECTRONICS INC. |
| Manufacturer Street | 4065 THEURER BOULEVARD |
| Manufacturer City | WINONA MN 55987 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55987 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3M LITTMANN ELECTRONIC STETHOSCOPE |
| Generic Name | STETHOSCOPE, ELECTRONIC 870.1875 DQD |
| Product Code | DQD |
| Date Received | 2013-11-12 |
| Model Number | 3100 |
| Catalog Number | NA |
| Lot Number | UNK |
| ID Number | NA |
| 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 | ST. PAUL MN 55144 US 55144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-11-12 |