SURGICAL PATTIE, 1/2 X 1/2 80-1400

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-02-14 for SURGICAL PATTIE, 1/2 X 1/2 80-1400 manufactured by Codman & Shurtleff, Inc..

Event Text Entries

[100249373] (b)(4). Upon completion of the investigation a follow up report will be filed.
Patient Sequence No: 1, Text Type: N, H10


[100249374] It was reported that multiple packs of surgical patties were not detectable by x-ray. The issue occurred during surgery. No reported adverse outcome to the patient or delay in surgery greater than 30 minutes. A similar device was used to complete the procedure. According to the customer, during the procedure, the surgeon viewed the surgical side under fluoroscopy and could not see any of the patties that he had placed. A second pack of patties was used and they were visible. After surgery, a third pack was tested and was also found not to be detectable.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1226348-2018-10139
MDR Report Key7270806
Report SourceHEALTH PROFESSIONAL
Date Received2018-02-14
Date of Event2018-01-24
Date Mfgr Received2018-03-05
Date Added to Maude2018-02-14
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR JAMES KENNEY
Manufacturer Street325 PARAMOUNT DRIVE
Manufacturer CityRAYNHAM MA 02767
Manufacturer CountryUS
Manufacturer Postal02767
Manufacturer Phone5088282726
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSURGICAL PATTIE, 1/2 X 1/2
Generic NameSURGICAL SPONGE
Product CodeHBN
Date Received2018-02-14
Returned To Mfg2018-02-06
Catalog Number80-1400
Lot NumberC58754
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerCODMAN & SHURTLEFF, INC.
Manufacturer Address325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767


Patients

Patient NumberTreatmentOutcomeDate
10 2018-02-14

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