FDA.reportPublic FDA data

MAUDE MDR 2296609

MDR report key
2296609
Report number
3006760724-2011-00048
Event key
0
Event type
3
Date of event
2011-05-31
Date received
2011-10-14
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
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
1UNI-SOLVE WIPESSOLVENT, ADHESIVE TAPESMITH & NEPHEW WOUND MANAGEMENTKOX4023000K234N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-10-1401. 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). PATIENT WAS ADMITTED TO (B)(6) HOSPITAL (B)(6). PATIENT DIAGNOSED WITH HAVING TWO DIFFERENT INFECTIONS, AND PHYSICIAN STATES THE INFECTIONS ARE VERY UNUSUAL.

N

Patient 1

ACTIVE INVESTIGATION IN PROGRESS; RESULTS OF INVESTIGATION TO BE PROVIDED IN A SUPPLEMENT REPORT.

N

Patient 1

NO PRODUCT WAS RETURNED BY THE CUSTOMER. CONTROL SAMPLES (FROM STOCK) OF THE REPORTED LOT 0K234 WERE ANALYZED BY AN INDEPENDENT TEST LABORATORY AND MET FINISHED PRODUCT SPECIFICATIONS WITH NO EVIDENCE OF MICROBIAL CONTAMINATION FOUND. BATCH RECORDS FOR THE LOT 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.