SOHEIN 55/33 SCALER SD55/33 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 1998-04-30 for SOHEIN 55/33 SCALER SD55/33 * manufactured by Premier Medical (mfg).

Event Text Entries

[95186] Co was advised by customer that an instrument of co's mfr had pitted on the working ends no injury was reported. Instrument tip was not broken.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2521453-1998-00001
• MDR Report Key: 166045
• Report Source: 08
• Date Received: 1998-04-30
• Date of Report: 1998-04-30
• Date of Event: 1998-02-18
• Date Mfgr Received: 1998-03-30
• Device Manufacturer Date: 1988-03-01
• Date Added to Maude: 1998-05-07
• 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: 0
• Reporter Occupation: DENTIST
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: SOHEIN 55/33 SCALER
• Generic Name: DENTAL HAND INSTRUMENT
• Product Code: EMN
• Date Received: 1998-04-30
• Returned To Mfg: 1998-03-11
• Model Number: SD55/33
• Catalog Number: *
• Lot Number: PD
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 161591
• Manufacturer: PREMIER MEDICAL (MFG)
• Manufacturer Address: 10090 SANDMEYER LANE PHILADELPHIA PA 19116 US
• Baseline Brand Name: SOHEIN 55/33 SCALER
• Baseline Generic Name: DENTAL HAND INSTRUMENT
• Baseline Model No: SD55/33
• Baseline Catalog No: *
• Baseline ID: *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1998-04-30