MAUDE Adverse Event Report: 3M HEALTH CARE 3M¿ LITTMAN® CLASSIC II¿ S.E. STETHOSCOPE; MANUAL STETHOSCOPE

Catalog Number	2201
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Hearing Impairment (1881)
Date of Event	12/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No information was provided.Device was returned for evaluation; evaluation is anticipated.End of report.
Event or Problem Description
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.
Additional Manufacturer Narrative
The eartip was returned for evaluation; the eartip returned does not visually match up with a newly produced, conforming eartip.The analysis showed that the eartip may have been over inserted on the eartube and that over the years of usage malformed to enlarge the mating hole that meets the eartube.The over insertion of eartips is something that can happen during assembly and is verified multiple times during production at different steps to detect this issue.End of report.

• Brand Name: 3M¿ LITTMAN® CLASSIC II¿ S.E. STETHOSCOPE
• Common Device Name: MANUAL STETHOSCOPE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• MDR Report Key: 8272669
• Report Number: 2110898-2019-00010
• Device Sequence Number: 13488163
• Product Code: LDE
• UDI-Device Identifier: 00707387766160
• UDI-Public: 00707387766160
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 2201
• Device Lot Number: 201401CU
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/15/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2018
• Supplement Date Received by Manufacturer: 12/30/2018
• Initial Report FDA Received Date: 01/23/2019
• Supplement Report FDA Received Date: 02/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 40 YR