MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-07-21 for 3M LITTMANN CLASSIC II SE STETHOSCOPE 2201 manufactured by 3m Health Care.
[481397]
The customer reported that around the end of may, she was using her stethoscope to check blood pressure. She noticed that the eartips were on the stethoscope, then opened it and placed it in her ears. The customer reported that one of the ear tips had fallen off and the eartube punctured her eardrum. The customer reported that she went to the emergency room, but did not receive any treatment from them. The customer reported that she subsequently visited an ent physician who told her that a clot was obscurring the membrane and disgnosed the hole as a puncture affecting 20% of the membrane. The customer reported that she was treated with a medrol dose pack and antibiotics, but that the physician did not want to perform a graft of the membrane. The customer stated that she had returned to work but has hearing loss, dizziness, tinnitus, and headaches.
Patient Sequence No: 1, Text Type: D, B5
[7790946]
The product was not sent back to 3m for evaluation and no lot number was provided. No evaluation of this device could be made. The device mfg date is unk because the customer did not provide a lot number. The 3m's product manual provides instructions for proper placement of the ear tips and use of the product. The 3m attributes this event to user error. If 3m receives significant new info regarding this event, including additional info regarding pt treatment or outcome, 3m will file a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2110898-2006-00009 |
| MDR Report Key | 739103 |
| Report Source | 05 |
| Date Received | 2006-07-21 |
| Date of Report | 2006-06-21 |
| Date Mfgr Received | 2006-06-21 |
| Date Added to Maude | 2006-07-25 |
| 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 HEALTH CARE PLANT |
| 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 | 3M LITTMANN CLASSIC II SE STETHOSCOPE |
| Generic Name | STETHOSCOPE, MANUAL |
| Product Code | LDE |
| Date Received | 2006-07-21 |
| Model Number | CLASSIC II SE |
| Catalog Number | 2201 |
| 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 | 726984 |
| Manufacturer | 3M HEALTH CARE |
| Manufacturer Address | 3M CENTER ST. PAUL MN 551441000 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2006-07-21 |