FDA.reportPublic FDA data

MAUDE MDR 3696331

MDR report key
3696331
Report number
1226348-2014-11330
Event key
0
Event type
3
Date of event
2014-03-10
Date received
2014-03-24
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
403
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
MR. JAMES KENNEY
Address
325 PARAMOUNT DRIVE RAYNHAM MA 02767 US
Phone
508-508-5088
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SURGICAL PATTIE 1/2 X 1/2SURGICAL SPONGECODMAN & SHURTLEFF, INC.FQA80-1400415307R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-03-2401. R

Event Narratives#

N

Patient 1

IT HAS BEEN COMMUNICATED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. SINCE A LOT NUMBER HAS BEEN PROVIDED A REVIEW OF THE MANUFACTURING RECORDS WILL BE REVIEWED. WE ANTICIPATE THAT THE EVALUATION WILL REVEAL THAT THE DEVICE CONFORMED TO SPECIFICATIONS PRIOR TO RELEASE. IF ANYTHING OTHERWISE IS FOUND THEN A FOLLOW UP REPORT WILL BE FILED. IF AT SOME POINT THE DEVICE DOES BECOME AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED, EVALUATED AND A FOLLOW UP REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED. DEVICE NOT RETURNED.

D

Patient 1

THE AFFILIATE REPORTED: NO PROCEDURE. DURING SET UP, THE PACKAGE SAID 10 ITEMS BUT THEY COUNTED THEM AND IT WAS ONLY 9. PRODUCT WAS DISCARDED. NO PHOTOS AVAILABLE. NO PATIENT INVOLVED. NO FURTHER INFORMATION AVAILABLE. THE PRODUCT WAS DISCARDED BY THE CUSTOMER.