MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-05-26 for LITTMANN CARDIOLOGY III STETHOSCOPE 3129 manufactured by 3m Health Care.
[15702343]
The customer reported that he was examining patients in his clinic when he put his stethoscope in his ears without realizing that one of the eartips was not on the stethoscope. The customer reported that he experienced pain in his right ear and that the stethoscope became stuck in his ear. He stated that an ent surgeon injected lidocaine in his ear but was still unable to remove the stethoscope. The customer reported that his tympanic membrance was punctured, and that the threads on the stethoscope's eartube had become hooked on the ossicles in his middle ear, leaving them damaged. He stated that doctors applied a collagen patch to his tympanic membrane and that the ossicles are healing. The customer reported that he believed he had a 50 decibel (db) hearing loss initially but that he thinks his ear is healing and improving daily. The pt has scheduled follow up appointments with an ent physician.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2006-00005 |
| MDR Report Key | 720779 |
| Report Source | 05 |
| Date Received | 2006-05-26 |
| Date of Report | 2006-04-27 |
| Date of Event | 2006-03-30 |
| Date Mfgr Received | 2006-04-27 |
| Date Added to Maude | 2006-06-01 |
| 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 | 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 COMPANY |
| Manufacturer Street | 601 22ND AVENUE SOUTH |
| 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 | 2006-05-26 |
| Model Number | CARDIOLOGY III |
| Catalog Number | 3129 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 709850 |
| Manufacturer | 3M HEALTH CARE |
| Manufacturer Address | * ST. PAUL MN * US |
| Baseline Brand Name | 3M LITTMANN STETHOSCOPE |
| Baseline Generic Name | MANUAL STETHOSCOPE |
| Baseline Model No | CARDIOLOGY III |
| Baseline Catalog No | 3127 |
| Baseline Device Family | LITTMANN STETHOSCOPE |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K821909 |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2006-05-26 |