MEDGYNE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-04-24 for MEDGYNE manufactured by .

Event Text Entries

[19958546] Thirty yo wf experienced hypotensive and bradycardia s/p laminaria insertion. Pt received pericervical lidocaine 1% 10mls prior to laminaria insertion. Seven laminaria inserted at 1015. Pt very uncomfortable, complains of abdominal cramping and feeling light headed, dizzy and thirsty. Bp 94/59 and hr 67 down from baseline -107/64; 82- 5min post insertion. Bp 76/48; hr 58 at 1035. Vs began to be monitored every 10 minutes. No improvement. At 1120, piv placed with ns kvo. Bp 80/59; hr = 56. At 1130, md gave atropine 1 mg infused iv push. Treated discomfort with percocet 5/235mg x 1 at 1135. Improvement of pt's bp and pulse x approximately 1 hr with subsequent recurrence of bradycardia and hypotension. Md notified and pt was admitted to hospital in 2009 for observation. Or procedure performed in the next day as planned.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5010919
• MDR Report Key: 1372250
• Date Received: 2009-04-24
• Date of Report: 2009-04-24
• Date of Event: 2009-04-21
• Date Added to Maude: 2009-05-05
• 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
• Reporter Occupation: PHARMACIST
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: MEDGYNE
• Generic Name: LAMINARIA
• Product Code: HDY
• Date Received: 2009-04-24
• Device Availability: N
• Device Sequence No: 1
• Device Event Key: 0

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2009-04-24