MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 1999-04-06 for LITTMANN CLASSIC II UNK manufactured by 3m Cambridge Med Div Plant.
[163764]
A dr alleged that the eartip on the stethoscope he was using had fallen off at some stage prior to performing resuscitation to a pt. The application of the stethoscopes' unprotected left ear-piece perforated his left tympanic membrane when he applied the stethoscope to auscultate the pts chest.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-1999-00004 |
| MDR Report Key | 218458 |
| Report Source | 01,05 |
| Date Received | 1999-04-06 |
| Date of Report | 1999-04-05 |
| Date of Event | 1999-02-08 |
| Date Mfgr Received | 1999-03-01 |
| Date Added to Maude | 1999-04-14 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LITTMANN CLASSIC II |
| Generic Name | STETHOSCOPE |
| Product Code | LDE |
| Date Received | 1999-04-06 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 211865 |
| Manufacturer | 3M CAMBRIDGE MED DIV PLANT |
| Manufacturer Address | 23 BAY STATE ROAD CAMBRIDGE MA 02138 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1999-04-06 |