FDA.reportPublic FDA data

MAUDE MDR 7011398

MDR report key
7011398
Report number
2210968-2017-71071
Event key
0
Event type
3
Date of event
2017-10-17
Date received
2017-11-08
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
DARLENE KYLE
Address
P.O. BOX 151, ROUTE 22 WEST SOMERVILLE 08876 US
Phone
908-908-9082
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SUTURE UNKNOWNSUTURE, NONABSORBABLEETHICON INC.GAOUNK* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-11-080

Event Narratives#

N

Patient 1

TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. ATTEMPTS ARE BEING MADE TO OBTAIN THE ADDITIONAL INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. 1. WAS THE PATIENT TREATMENT ALTERED IN ANYWAY DUE TO THE PROLONGED SURGERY TIME? IF YES, PLEASE EXPLAIN 2. WAS THERE ANY PATIENT IMPACT (IE. ADDITIONAL TREATMENT REQUIRED) AND/OR ADVERSE PATIENT OUTCOME DUE TO THE PROLONGED SURGERY ? 3. WERE THERE ANY UNEXPECTED OUTCOMES OR COMPLICATIONS AS A RESULT OF THE PROLONGED SURGERY TIME? 4. WAS THE PATIENT TREATMENT ALTERED IN ANYWAY DUE TO THE PROLONGED SURGERY TIME? IF YES, PLEASE EXPLAIN. 5. WAS THE NEEDLE REMOVED DURING THE FIRST PROCEDURE? 6. WHAT IS THE PRODUCT CODE AND LOT NUMBER?

D

Patient 1

IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGICAL PROCEDURE ON (B)(6) 2017 AND THE UNKNOWN SUTURE WAS USED. DURING THE PROCEDURE, WHEN HOLDING THE SUTURE WITH A LAPAROSCOPIC NEEDLE HOLDER UPON INSERTION INTO THE TROCAR, THE NEEDLE WAS DETACHED FROM THE STRAND. X-RAYS WERE TAKEN AND THE NEEDLE WAS FOUND INSIDE THE PATIENT AND REMOVED. THE PROCEDURE WAS COMPLETED AS USUAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.