MAUDE Adverse Event Report: 3M HEALTH CARE 3M¿ LITTMAN® CLASSIC¿ III STETHOSCOPE; MANUAL STETHOSCOPE

Catalog Number 5622

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Irritation (1941); Rash (2033); Skin Irritation (2076)

Event Date 10/31/2018

Event Type  Injury  

Manufacturer Narrative

No information was provided.Device was not returned for evaluation.End of report.

Event Description

A female alleged two ear infections on separate occasions and a rash on the neck.Use of a 3m¿ littman® classic¿ iii monitoring stethoscope began in (b)(6) 2018.She was seen in urgent care and in the emergency room on separate occasions and was treated with prescription antibiotics, an oral steroid and ear drops.The rash resolved and the most recent ear infection is resolving.

• Brand Name: 3M¿ LITTMAN® CLASSIC¿ III STETHOSCOPE
• Type of Device: MANUAL STETHOSCOPE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• Manufacturer (Section G): 3M HEALTH CARE; 5400 route b; columbia MO 65202 9348
• Manufacturer Contact: dianne gibbs ; 3m center, building 275-5w-06; 2510 conway ave; st. paul, MN 55144 ; 6517379117
• MDR Report Key: 8272573
• MDR Text Key: 133937335
• Report Number: 2110898-2019-00009
• Device Sequence Number: 1
• Product Code: LDE
• UDI-Device Identifier: 00707387771898
• UDI-Public: 00707387771898
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/23/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 5622
• Device Lot Number: 201711CD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/02/2019
• Initial Date FDA Received: 01/23/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 44 YR