AURICAL AUD/PMM, 1081 8-04-14500

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-09-03 for AURICAL AUD/PMM, 1081 8-04-14500 manufactured by Natus Medical Denmark (gn Otometrics).

MAUDE Entry Details

• Report Number: 9612197-2019-00010
• MDR Report Key: 8954797
• Report Source: HEALTH PROFESSIONAL,USER FACI
• Date Received: 2019-09-03
• Date of Report: 2019-10-02
• Date of Event: 2018-11-09
• Device Manufacturer Date: 2019-09-23
• Date Added to Maude: 2019-09-03
• 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: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MISS LOUISE CALLANAN
• Manufacturer Street: IDA BUSINESS PARK GORT
• Manufacturer City: GALWAY, CONNAUGHT H91PD92
• Manufacturer Country: DA
• Manufacturer Postal: H91PD92
• Manufacturer G1: NATUS MEDICAL DENMARK (GN OTOMETRICS)
• Manufacturer Street: HOERSKAETTEN 9
• Manufacturer City: TAASTRUP, 2630
• Manufacturer Country: DA
• Manufacturer Postal Code: 2630
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: AURICAL AUD/PMM, 1081
• Generic Name: AURICAL AUD/PMM, 1081
• Product Code: EWO
• Date Received: 2019-09-03
• Returned To Mfg: 2018-11-13
• Model Number: 8-04-14500
• Catalog Number: 8-04-14500
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: DA
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: NATUS MEDICAL DENMARK (GN OTOMETRICS)
• Manufacturer Address: HOERSKAETTEN 9 TAASTRUP, 2630 DA 2630

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2019-09-03