CIRC BELL AND INSERT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-12-22 for CIRC BELL AND INSERT manufactured by Centurion Medical Products Corp..

Event Text Entries

[1746320] Surgeon applied gomco and bell to infant and turned the clamp until tight. Surgeon concerned that something did not feel right so rather than make usual incision with the blade, made a small "nick". There was much blood indicating that the clamp had not caused hemostasis at which time surgeon removed the gomco and bell, held pressure until rn could get another 1. 1 bell with a matching 1. 1 ring. New ring placed on gomco and bell applied to infant and procedure completed without incidence. Approx 5 ml of blood loss due to bell (1. 1) not matched with correct ring (package from centurion had a 1. 3 ring in the 1. 1 package).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5018685
MDR Report Key1938524
Date Received2010-12-22
Date of Report2010-12-15
Date of Event2010-12-08
Date Added to Maude2011-01-12
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Generic NameCIRC BELL AND INSERT
Product CodeFHG
Date Received2010-12-22
Lot Number2010080901
ID NumberREORDER 110CR
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Sequence No1
Device Event Key0
ManufacturerCENTURION MEDICAL PRODUCTS CORP.
Manufacturer AddressWILLIAMSTON MI 48895 US 48895


Patients

Patient NumberTreatmentOutcomeDate
101. Life Threatening; 2. Required No Informationntervention 2010-12-22

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