MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2005-11-14 for LITTMANN CARDIOLOGY III STETHOSCOPE 3128 manufactured by 3m Health Care.
[19150657]
The user (a primary care paramedic) was conducting an assessment of a pt when the user injured himself by extending the earpieces of the stethoscope with one hand and allowing them to snap closed on his ears. The user had not realized that one of the eartips was not present on the tube, and therefore the steel ear tube projected into his ear canal. The user reported severe pain including nausea and vertigo, in addition to bleeding, as a result of the incident. The user was examined by a resident ent physician at the hosp, and it was discovered that the tubing had made it around the anatomical bend in the ear canal, creating a large laceration into the canal, but not injuring the tympanic membrane. The user experienced bleeding for up to 3 days, affecting his hearing. The resulting blood clots were suctioned off. The user was examined by his family physician in 2005 and it was then confirmed that there was no damage to the tympanic membrane. Although a few small clots remained, the user had no permanent damage or impairment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2005-00017 |
| MDR Report Key | 646861 |
| Report Source | 01,05,07 |
| Date Received | 2005-11-14 |
| Date of Report | 2005-10-11 |
| Date of Event | 2005-10-03 |
| Date Mfgr Received | 2005-10-11 |
| Device Manufacturer Date | 1999-08-01 |
| Date Added to Maude | 2005-11-22 |
| 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 | PARAMEDIC |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | GINGER CANTOR |
| Manufacturer Street | 3M CENTER, BUILDING 275-5W-06 |
| Manufacturer City | ST. PAUL MN 551441000 |
| Manufacturer Country | US |
| Manufacturer Postal | 551441000 |
| Manufacturer Phone | 6517362101 |
| Manufacturer G1 | 3M HEALTH CARE PLANT |
| Manufacturer Street | 601 22ND AVE S |
| Manufacturer City | BROOKINGS SD 57006 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 57006 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LITTMANN CARDIOLOGY III STETHOSCOPE |
| Generic Name | MANUAL STETHOSCOPE |
| Product Code | LDE |
| Date Received | 2005-11-14 |
| Model Number | NA |
| Catalog Number | 3128 |
| Lot Number | M9H43079 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 636350 |
| Manufacturer | 3M HEALTH CARE |
| Manufacturer Address | * ST. PAUL MN 551441000 US |
| Baseline Brand Name | LITTMANN CARDIOLOGY III STETHOSCOPE |
| Baseline Generic Name | MANUAL STETHOSCOPE |
| Baseline Model No | NA |
| Baseline Catalog No | 3128 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2005-11-14 |