QWIK CONNECT SPIRAL *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-08-31 for QWIK CONNECT SPIRAL * manufactured by Corometrics.

Event Text Entries

[98142] During assessment of newborn, a laceration approx 1 cm wide was noted in the left parietal region of the head which was sutured using 1 stitch. Cause unk. Both an internal lead and an intrauterine pressure catheter was used during the labor. Both mfrs notified.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 185155
• MDR Report Key: 185155
• Date Received: 1998-08-31
• Date of Report: 1998-08-26
• Date of Event: 1998-08-18
• Date Facility Aware: 1998-08-18
• Report Date: 1998-08-26
• Date Reported to FDA: 1998-08-26
• Date Reported to Mfgr: 1998-08-26
• Date Added to Maude: 1998-09-03
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• 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: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: QWIK CONNECT SPIRAL
• Generic Name: COROMETRICS
• Product Code: KXO
• Date Received: 1998-08-31
• Model Number: *
• Catalog Number: *
• Lot Number: 36V0
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 179976
• Manufacturer: COROMETRICS
• Manufacturer Address: 61 BARNES PARK RD NO. WALLINGFORD CT 06492 US

Device Sequence Number: 2

• Brand Name: SOFTRANS
• Generic Name: INTRAUTERINE PRESSURE CATH
• Product Code: KXO
• Date Received: 1998-08-31
• Model Number: 31103826
• Catalog Number: *
• Lot Number: 073198
• ID Number: *
• Device Availability: N
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 179979
• Manufacturer: GRAPHIC CONTROLS
• Manufacturer Address: POB 1274 BUFFALO NY 14240 US
• Baseline Brand Name: LIFETRACE SOFTRANS IUPC
• Baseline Generic Name: INTRAUTERINE PRESSURE CATHETER
• Baseline Model No: IUP 4000
• Baseline Catalog No: 31103826
• Baseline ID: NA
• Baseline Device Family: INTRAUTERINE PRESSURE CATHETER
• Baseline Shelf Life Contained: Y
• Baseline Shelf Life [Months]: 12
• Baseline PMA Flag: N
• Baseline 510K PMN: Y
• Premarket Notification: K950498
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: N

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1998-08-31