NS252 INNERVATOR NS252JWD

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1997-09-06 for NS252 INNERVATOR NS252JWD manufactured by Fisher & Paykel Electronics Ltd..

Event Text Entries

[16398394] Pt received 3rd degree burns that were found under the electrode pads that were clipped with alligator clips on the left forearm. The clips were used to secure the pns electrode site. One small insulated alligator clip came with the pns and the hosp staff added a larger uninsulated alligator clip. There were two burns, one of 1 cm, the other was 1. 5 cm.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 9611451-1997-00001
• MDR Report Key: 118214
• Report Source: 05,06
• Date Received: 1997-09-06
• Date of Report: 1997-08-07
• Date of Event: 1997-07-21
• Date Mfgr Received: 1997-08-07
• Device Manufacturer Date: 1993-07-01
• Date Added to Maude: 1997-09-10
• 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
• 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: NS252 INNERVATOR
• Generic Name: PERIPHERAL NERVE STIMULATOR
• Product Code: KOI
• Date Received: 1997-09-06
• Model Number: NS252JWD
• Catalog Number: NS252JWD
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 115917
• Manufacturer: FISHER & PAYKEL ELECTRONICS LTD.
• Manufacturer Address: 25 CARBINE ROAD/PO BOX 14-348 PANMURE, AUCKLAND NZ
• Baseline Brand Name: NS252 INNERVATOR
• Baseline Generic Name: PERIPHERAL NERVE STIMULATOR
• Baseline Model No: NS252JWD
• Baseline Catalog No: NS252JWD
• Baseline ID: *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1997-09-06