SWANSON G4260010

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-04-23 for SWANSON G4260010 manufactured by Wright Medical Technology, Inc..

Event Text Entries

[106184757] The product was not returned; however, a radiographic image was provided. Review of the provided image shows two implanted swanson devices with grommets.
Patient Sequence No: 1, Text Type: N, H10


[106184758] It was reported that the patient underwent a surgical procedure with grommets implanted in the right thumb and index finger mp joint. Allegedly, the patient has complained of pain and swelling in the insertion site as well as being feverish since the surgery. X-rays did not indicate any problems. Crp was (b)(6). The patient took antibiotics (b)(6) but it was not responding. The patient is undergoing testing to see if there is an allergic reaction to silicon or titanium.
Patient Sequence No: 1, Text Type: D, B5


[111227911]
Patient Sequence No: 1, Text Type: N, H10


[111227912] The patient underwent allergy testing with a skin patch. The test result is negative. The pain at the thumb is improving.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1043534-2018-00025
MDR Report Key7450886
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2018-04-23
Date of Report2018-03-26
Date Facility Aware2018-03-26
Date Mfgr Received2018-05-16
Device Manufacturer Date2016-03-01
Date Added to Maude2018-04-23
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 Street1023 CHERRY ROAD
Manufacturer City38117
Manufacturer CountryUS
Manufacturer Postal38117
Manufacturer Phone901451-631
Manufacturer G1WRIGHT MEDICAL TECHNOLOGY, INC.
Manufacturer Street11576 MEMPHIS ARLINGTON RD
Manufacturer City38002
Manufacturer CountryUS
Manufacturer Postal Code38002
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSWANSON
Generic NamePROSTHESIS, TOE, CONSTRAINED, POLYMER
Product CodeKWH
Date Received2018-04-23
Model NumberG4260010
Lot Number1573904
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerWRIGHT MEDICAL TECHNOLOGY, INC.
Manufacturer Address11576 MEMPHIS ARLINGTON RD 38002 US 38002


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-04-23

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