MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2003-10-31 for 3M LITTMANN PEDIATRIC STETHOSCOPE 2113 manufactured by 3m Health Care.
[15738597]
A customer reported that a doctor complained of pain in their left ear after placing the stethoscope eartips in their ears. The doctor went to the emergency room and was diagnosed with a left ear drum perforation. A hearing test showed loss of hearing. The doctor will be retested in four weeks.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2003-00010 |
| MDR Report Key | 493440 |
| Report Source | 06,07 |
| Date Received | 2003-10-31 |
| Date of Report | 2003-09-02 |
| Date of Event | 2003-08-29 |
| Date Mfgr Received | 2003-09-02 |
| Date Added to Maude | 2003-11-05 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LINDA JOHNSEN |
| Manufacturer Street | BUILDING 275-5W-06 |
| Manufacturer City | ST. PAUL MN 55144 |
| Manufacturer Country | US |
| Manufacturer Postal | 55144 |
| Manufacturer Phone | 6517374376 |
| Manufacturer G1 | 3M CAMBRIDGE MEDICAL DIV. |
| Manufacturer Street | 23 BAY STATE ROAD |
| Manufacturer City | CAMBRIDGE MA 02138 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02138 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3M LITTMANN PEDIATRIC STETHOSCOPE |
| Generic Name | MANUAL STETHOSCOPE |
| Product Code | LDE |
| Date Received | 2003-10-31 |
| Model Number | NA |
| Catalog Number | 2113 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 482146 |
| Manufacturer | 3M HEALTH CARE |
| Manufacturer Address | 3M CENTER, BLDG. 275-5W-06 ST. PAUL MN 55144 US |
| Baseline Brand Name | 3M LITTMANN PEDIATRIC STETHOSCOPE |
| Baseline Generic Name | MANUAL STETHOSCOPE |
| Baseline Model No | NA |
| Baseline Catalog No | 2113 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-10-31 |