FDA.reportPublic FDA data

MAUDE MDR 3701310

MDR report key
3701310
Report number
1038548-2014-00035
Event key
0
Event type
3
Date of event
2013-12-01
Date received
2014-03-26
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
500
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
JILL RITTORNO
Address
75 NORTH FAIRWAY DRIVE VERNON HILLS IL 60061 US
Phone
847-847-8473
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1UNK V. MUELLERRETRACTOR, FIBEROPTICCAREFUSIONFDGUNK V. MUELLERR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-03-2601. O

Event Narratives#

D

Patient 1

BURN MAUDE REPORT # (B)(4) WAS RECEIVED 05 MARCH 2014. THE REPORT STATES: "AT TEBBETTS LIGHTED BREAST RETRACTOR WAS BEING USED DURING BREAST SURGERY. THE LIGHT SOURCE A LUXTEX MLX BY INTEGRA WAS RUNNING WITH THE LIGHT SOURCE AT 100% THROUGHOUT THE CASE. THE RETRACTOR WAS MOVED FROM THE MAYO STAND ONTO THE PATIENTS DIRECT SKIN. AN APPROXIMATELY 4CM BURN DEVELOPED INFERIOR TO THE RIGHT BREAST, APPEARING LIGHT PINK IN COLOR. OINTMENT AND A WOUND DRESSING WERE APPLIED TO THE AREA. DURING A FOLLOW-UP APPOINTMENT, ANOTHER WOUND DRESSING WAS APPLIED. THE PROCEDURE WAS A BILATERAL SILICONE PERMANENT BREAST IMPLANT WITH THE REMOVAL OF SOFT TISSUE EXPANDERS. THE PATIENT WAS A (B)(6) OLD FEMALE PATIENT, (B)(6) WITH AN ALLERGY TO ADHESIVE BANDAGE. THE TWO TEBBETTS RETRACTORS THAT WERE LISTED WERE 88-1087 AND 88-1088.

N

Patient 1

(B)(4). SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP EMDR WILL BE SUBMITTED.

N

Patient 1

(B)(4). PER EMAIL FROM THE CUSTOMER 18 (B)(6) 2014. THIS WAS A DUPLICATE OF REPORTABLE COMPLAINT (B)(4)(1038548-2013-00033). PLEASE BE INFORMED THAT THIS COMPLAINT WILL BE CLOSED OUT IN OUR SYSTEM AS A DUPLICATE.