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 2005-04-04 for 3M LITTMANN MASTER CARDIOLOGY UNK manufactured by 3m Health Care.
[368303]
The customer (the patient) reported that when they was removing the stethoscope from their ears with one hand, the eartip flicked onto their eye, resulting in an eye injury. The customer alleges that they have experienced a decreased in their sight due to the injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2005-00008 |
| MDR Report Key | 588742 |
| Report Source | 01,05,07 |
| Date Received | 2005-04-04 |
| Date of Report | 2004-04-23 |
| Date of Event | 2003-08-27 |
| Date Mfgr Received | 2004-04-23 |
| Date Added to Maude | 2005-04-08 |
| 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 BLDG 275-5W-06 |
| Manufacturer City | ST. PAUL MN 551441000 |
| Manufacturer Country | US |
| Manufacturer Postal | 551441000 |
| Manufacturer Phone | 6517362101 |
| Manufacturer G1 | 3M BROOKINGS / HEALTH CARE PLANT |
| Manufacturer Street | 601 22ND AVENUE SOUTH |
| Manufacturer City | BROOKINGS SD 57006522 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 57006 5227 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3M LITTMANN MASTER CARDIOLOGY |
| Generic Name | MANUAL STETHOSCOPE |
| Product Code | LDE |
| Date Received | 2005-04-04 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| 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 | 578580 |
| Manufacturer | 3M HEALTH CARE |
| Manufacturer Address | 3M CENTER, BLDG. 275-5W-06 ST. PAUL MN * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-04-04 |