BINOCULAR INDIRECT OTOSCOPE 75201

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2005-03-11 for BINOCULAR INDIRECT OTOSCOPE 75201 manufactured by Welch Allyn.

Event Text Entries

[373604] Internal elctrical shortage within battery pack. Caused base to melt.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1316463-2005-00004
• MDR Report Key: 583312
• Report Source: 07
• Date Received: 2005-03-11
• Date of Report: 2005-03-11
• Date of Event: 2005-02-21
• Date Mfgr Received: 2005-02-21
• Date Added to Maude: 2005-03-22
• 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: SERVICE PERSONNEL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Manufacturer Contact: CHRISTOPHER KLACZYK
• Manufacturer Street: 4341 STATE STREET ROAD P.O. BOX 220
• Manufacturer City: SKANEATELES FALLS NY 131530220
• Manufacturer Country: US
• Manufacturer Postal: 131530220
• Manufacturer Phone: 3156853694
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: BINOCULAR INDIRECT OTOSCOPE
• Generic Name: OTOSCOPE
• Product Code: ERA
• Date Received: 2005-03-11
• Returned To Mfg: 2005-02-21
• Model Number: NA
• Catalog Number: 75201
• Lot Number: UNK
• ID Number: NA
• Operator: OTHER
• Device Availability: R
• Device Eval'ed by Mfgr: N
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 573141
• Manufacturer: WELCH ALLYN
• Manufacturer Address: 4341 STATE ST. RD. P.O. BOX 220 SKANEATELES FALLS NY 131530220 US
• Baseline Brand Name: BINOCULAR INDIRECT OTOSCOPE
• Baseline Generic Name: OTOSCOPE
• Baseline Model No: NA
• Baseline Catalog No: 75201
• Baseline ID: NA

Patients

Patient Number	Treatment	Outcome	Date
1	0		2005-03-11