RUGGLES KERRISON 1MM RD41191D1

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-29 for RUGGLES KERRISON 1MM RD41191D1 manufactured by Integra York Pa, Inc..

Event Text Entries

[135004619] Integra ruggles kerrisons purchased and used. Upon the first time using them, none of them were able to cut tissue.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5083545
• MDR Report Key: 8292873
• Date Received: 2019-01-29
• Date of Report: 2019-01-28
• Date of Event: 2019-01-23
• Date Added to Maude: 2019-01-31
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Sequence Number: 1

• Brand Name: RUGGLES KERRISON 1MM
• Generic Name: RONGEUR, MANUAL
• Product Code: HAE
• Date Received: 2019-01-29
• Model Number: 1MM
• Catalog Number: RD41191D1
• Lot Number: 100161-1803
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: INTEGRA YORK PA, INC.

Device Sequence Number: 2

• Brand Name: RUGGLES KERRISON 2MM
• Generic Name: RONGEUR, MANUAL
• Product Code: HAE
• Date Received: 2019-01-29
• Model Number: 2 MM LONG KERRISON
• Catalog Number: RD41192DT, RD488DT
• Lot Number: 1805, 1611
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: INTEGRA YORK PA, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-01-29