PURSTRING 020730

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-09-15 for PURSTRING 020730 manufactured by Us Surgical Puerto Rico.

Event Text Entries

[86275742] A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[86275743] According to the reporter, on (b)(6) 2017, intra-operatively in colic surgery, the device was broken, the wire was crimped, fallen at the opening of the blister. They create a "manual scholarship" to resolve the issue and complete the case. The patient was alive with no injury.
Patient Sequence No: 1, Text Type: D, B5


[117475130] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[117475131] Additional information: the suture was not attached on the instrument.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2647580-2017-06601
MDR Report Key6868153
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2017-09-15
Date of Report2017-11-10
Date of Event2017-08-17
Date Mfgr Received2017-10-12
Device Manufacturer Date2016-10-14
Date Added to Maude2017-09-15
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 ContactSHARON MURPHY
Manufacturer Street60 MIDDLETOWN AVE
Manufacturer CityNORTH HAVEN CT 06473
Manufacturer CountryUS
Manufacturer Postal06473
Manufacturer Phone2034925267
Manufacturer G1US SURGICAL PUERTO RICO
Manufacturer Street201 SABANETAS INDUSTRIAL PARK
Manufacturer CityPONCE PR 007164401
Manufacturer CountryUS
Manufacturer Postal Code007164401
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePURSTRING
Generic NameCLAMP, SURGICAL, GENERAL & PLASTIC SURGERY
Product CodeGDJ
Date Received2017-09-15
Model Number020730
Catalog Number020730
Lot NumberP6K0386X
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerUS SURGICAL PUERTO RICO
Manufacturer Address201 SABANETAS INDUSTRIAL PARK PONCE PR 007164401 US 007164401


Patients

Patient NumberTreatmentOutcomeDate
10 2017-09-15

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.