FDA.reportPublic FDA data

MAUDE MDR 9908485

MDR report key
9908485
Report number
3005075853-2020-01891
Event key
0
Event type
3
Date of event
2020-03-05
Date received
2020-03-31
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. KARA DITTY-BOVARD
Address
475 CALLE C GUAYNABO 00969 *
Phone
610-610-6107
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PWRD ECH FLEX 45MM 34CM SHAFTSTAPLE, IMPLANTABLEETHICON ENDO-SURGERY, LLC.GDWPSE45APSE45AT95333N R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-310

Event Narratives#

No narrative records found.