FDA.reportPublic FDA data

MAUDE MDR 3058035

MDR report key
3058035
Report number
2210968-2013-03895
Event key
0
Event type
3
Date received
2013-04-15
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. KATHY RICE
Address
4545 CREEK ROAD MAIL LOCATION 120 CINCINNATI OH 45242 US
Phone
513-513-5133
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ETHIBOND EXTRA & EXCEL POLYESTER SUTURESUTURE, NON ABSORBABLEETHICON, INCGASNAEH7909HEM2CGMN0Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-04-1501. R

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT A PATIENT UNDERWENT FUNNEL BREAST SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED AS FIXATION FOR THE IMPLANT. POST OPERATIVELY THE PATIENT DEVELOPED A MASSIVE WOUND INFECTION WHICH RESULTED IN ANOTHER SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

N

Patient 1

(B)(4). THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE MEDWATCH 2210968-2013-03896. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

N

Patient 1

(B)(4): REPRESENTATIVE SAMPLES FROM THE SAME LOT NUMBER AS THE ACTUAL DEVICE WERE RETURNED FOR EVALUATION. PACKAGING INTEGRITY TESTING MET THE REQUIREMENTS.