MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2013-11-04 for 3M LITTMANN MANUAL STETHOSCOPE UNK manufactured by 3m Health Care.
[4007006]
It was reported that a user of a stethoscope injured the area between his middle and external right ear. The ear tip came off the binaural part of the stethoscope. The user did not realize this had occurred when the stethoscope was removed from his pocket and placed into his ear. Reportedly there was bleeding which was stopped at the hospital.
Patient Sequence No: 1, Text Type: D, B5
[11275725]
The initial reporter name from the following hospital was not provided. Information was obtained from 3m head office located in (b)(4). (b)(6). Actual used device was not returned. Without lot number it is not possible to determine the manufacture date. Without the lot number it is difficult to determine what type of eartips were used on this scope. Company 3m implemented a change from thread to snap to minimize eartips coming off from the stethoscope.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2110898-2013-00068 |
| MDR Report Key | 3472535 |
| Report Source | 05,06,07 |
| Date Received | 2013-11-04 |
| Date of Report | 2013-08-19 |
| Date of Event | 2012-11-19 |
| Date Mfgr Received | 2013-08-19 |
| Date Added to Maude | 2013-12-24 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | LINDA JOHNSEN, SPECIALIST |
| Manufacturer Street | 3M CENTER, BLDG. 275-5W-06 |
| Manufacturer City | ST. PAUL MN 551441000 |
| Manufacturer Country | US |
| Manufacturer Postal | 551441000 |
| Manufacturer Phone | 6517374376 |
| Manufacturer G1 | 3M COMPANY |
| Manufacturer Street | 5400 ROUTE B |
| Manufacturer City | COLUMBIA MO 65202 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 65202 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3M LITTMANN MANUAL STETHOSCOPE |
| Generic Name | STETHOSCOPE, MANUAL LDE 870.1875 |
| Product Code | LDE |
| Date Received | 2013-11-04 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M HEALTH CARE |
| Manufacturer Address | ST. PAUL MN 55144 US 55144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-11-04 |