FDA.reportPublic FDA data

MAUDE MDR 3083073

MDR report key
3083073
Report number
2210968-2013-04660
Event key
0
Event type
3
Date received
2013-04-29
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, INC.GASNA10X42NIR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-04-2901. R

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT A PEDIATRIC PATIENT UNDERWENT AN UMBILICAL HERNIA REPAIR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. APPROXIMATELY 4 TO 6 WEEKS POST-OPERATIVELY, THE PATIENT EXPERIENCED SPITTING OF THE SUTURE AT THE UMBILICUS . THE PATIENT UNDERWENT A SECOND SURGERY TO REMOVE THE SUTURES. DURING THE PROCEDURE, GRANULOMA FORMATION AND TISSUE BREAKDOWN WERE FOUND. ADDITIONAL INFORMATION REQUESTED.

N

Patient 1

(B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2013-04661. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.