FDA.reportPublic FDA data

MAUDE MDR 2226144

MDR report key
2226144
Report number
3006760724-2011-00037
Event key
0
Event type
3
Date of event
2011-05-04
Date received
2011-08-29
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
MR TERRY MCMAHON
Address
970 LAKE CARILLON DRIVE SUITE 110 ST. PETERSBURG FL 33716 US
Phone
727-727-7273
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1UNISOLVE WIPESSOLVENT, ADHESIVE TAPESMITH & NEPHEW WOUND MANAGEMENTKOX402300UNKNOWN* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-08-2901. H

Event Narratives#

D

Patient 1

THIS UNSOLVED COMPLAINT WAS RECEIVED POST SMITH & NEPHEW'S REMEDIAL ACTION (VOLUNTARY RECALL) TO PREVENT AN UNREASONABLE RISK OF SUBSTANTIAL HARM TO THE PUBLIC HEALTH (REF. RECALL #3006760724-04-06-2011-001R). ADVERSE INCIDENT (B)(6) OF 2010 STOMA AREA WAS PUFFY AND RED RESULTING IN HOSPITALIZATION AND SURGERY TO REMOVE INFECTION. INFECTION RETURNED IN (B)(6) 2011 REQUIRING FURTHER MEDICAL ATTENTION. PERSISTENT LOW GRADE FEVER. AREA SURROUNDING INFECTION HAS TURNED GRAY.

N

Patient 1

SMITH & NEPHEW WAS CONTACTED REGARDING THE ABOVE DESCRIBED INCIDENT, WHICH WAS REPORTED AS A FIELD COMPLAINT FOR "INFECTION-SITE/LOCAL". NO PRODUCT WAS RETURNED BY THE CUSTOMER AND NO LOT NUMBER WAS REPORTED. CONTROL SAMPLES (FROM STOCK) OF MULTIPLE LOTS OF UNI-SOLVE WIPES, WERE ANALYZED BY AN INDEPENDENT TEST LABORATORY AND MET FINISHED PRODUCT SPECIFICATIONS WITH NO EVIDENCE OF MICROBIAL CONTAMINATION FOUND. BATCH RECORDS FOR THE LOTS INDICATE ALL SPECIFICATIONS WERE MET AT THE TIME OF RELEASE AND NO INCONSISTENCIES WERE NOTED. AN INDEPENDENT MEDICAL REVIEW CONCLUDED THERE WAS NO CORRELATION BETWEEN THE REPORTED SYMPTOMS AND THE USE OF UNI-SOLVE WIPES. (B)(4)