MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-01-23 for 3M? LITTMAN? CLASSIC II? S.E. STETHOSCOPE 2201 manufactured by 3m Health Care.
[133931765]
No information was provided. Device was returned for evaluation; evaluation is anticipated. End of report.
Patient Sequence No: 1, Text Type: N, H10
[133931766]
A male reported an alleged injury of the right tympanic membrane after an ear tip fell off a 3m? Littman? Classic? Ii s. E. Stethoscope. The stethoscope was used for approximately one week. Outpatient care was received and the eardrum puncture recovered; however, there is a little difference in hearing performance noticed between the left and right ear.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2019-00010 |
| MDR Report Key | 8272669 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-01-23 |
| Date of Report | 2019-02-25 |
| Date of Event | 2018-12-12 |
| Date Mfgr Received | 2018-12-30 |
| Date Added to Maude | 2019-01-23 |
| 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 | 3 |
| Manufacturer Contact | MS. DIANNE GIBBS |
| Manufacturer Street | 3M CENTER, BUILDING 275-5W-06 2510 CONWAY AVE |
| Manufacturer City | ST. PAUL MN 55144 |
| Manufacturer Country | US |
| Manufacturer Postal | 55144 |
| Manufacturer Phone | 6517379117 |
| Manufacturer G1 | 3M HEALTH CARE |
| Manufacturer Street | 5400 ROUTE B |
| Manufacturer City | COLUMBIA MO 652029348 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 652029348 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3M? LITTMAN? CLASSIC II? S.E. STETHOSCOPE |
| Generic Name | MANUAL STETHOSCOPE |
| Product Code | LDE |
| Date Received | 2019-01-23 |
| Returned To Mfg | 2019-01-15 |
| Catalog Number | 2201 |
| Lot Number | 201401CU |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M HEALTH CARE |
| Manufacturer Address | 2510 CONWAY AVE ST. PAUL MN 55144 US 55144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2019-01-23 |