FDA.reportPublic FDA data

MAUDE MDR 6636078

MDR report key
6636078
Report number
8043484-2017-00163
Event key
0
Event type
3
Date of event
2017-05-15
Date received
2017-06-13
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR MARKUS POETTKER
Address
SCHACHENALLEE 29 AARAU 5001 SZ
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1IODOSORB GEL 10G USA CTN 4BEADS, HYDROPHILIC, FOR WOUND EXUDATE ABSORPTIONSMITH & NEPHEW MEDICAL LTD.KOZ6606063066060630N *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-06-130

Event Narratives#

N

Patient 1

D

Patient 1

IT WAS REPORTED THAT A PATIENT HAD A REACTION TO IODOSORB WITHIN 10MINS OF APPLICATION TO WOUND.

N

Patient 1

N

Patient 1

THE ASSOCIATED COMPLAINT DEVICES WERE NOT RETURNED FOR EVALUATION. PLEASE SEE ATTACHED FOR INVESTIGATION RESULTS.