FDA.reportPublic FDA data

MAUDE MDR 2251027

MDR report key
2251027
Report number
3006760724-2011-00044
Event key
0
Event type
3
Date of event
2011-05-23
Date received
2011-09-16
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 MANAGEMENTKOX4023000050*

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-09-1601. H

Event Narratives#

D

Patient 1

THIS UNISOLVE 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 EXPERIENCING PAIN IN LUNGS. RECENTLY DISCHARGED FROM HOSPITAL, DIAGNOSED WITH HAVING (B)(6). THREE HOSPITAL VISITS SINCE USING UNI-SOLVE WIPES, FROM (B)(6) 2011.

N

Patient 1

THERE WERE NO SAMPLES RETURNED BY THE CUSTOMER AND SO COMPLAINT CANNOT BE CONFIRMED. THE BATCH RECORDS FOR THESE LOTS WERE REVIEWED AND CONFIRMED THAT PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO THE SPECIFICATIONS. LOT 0050 WAS MANUFACTURED BY (B)(4) AND RELEASED IN APRIL/ MAY 2011 AND LOT 523633 WAS MANUFACTURED AND RELEASED IN JULY 2009. (B)(4). THERE WERE NO CHANGES MADE TO THE MANUFACTURING PROCESS OR INGREDIENTS. ADDITIONALLY MICROBIAL LIMIT TESTING WAS PERFORMED ON THIS LOT 0050 PRIOR TO RELEASE AND CONFIRMED THAT PRODUCT WAS NEGATIVE FOR E-COLI. THE PRODUCT IS COMPRISED OF ORGANIC SOLVENTS AND IS NOT CONDUCIVE TO MICROBIAL ACTIVITY. UNI-SOLVE ADHESIVE REMOVER IS FORMULATED TO REDUCE ADHESIVE TRAUMA TO THE SKIN BY THOROUGHLY DISSOLVING DRESSING TAPE AND APPLIANCE ADHESIVES- HYDROCOLLOID-BASED, ACRYLIC-BASED AND RUBBER-BASED ADHESIVES. SOME OTHER ADVERSE EVENT COMPLAINTS HAVE BEEN REPORTED FOR THIS LOT CODE. THERE IS NOT ENOUGH INFORMATION IN THE COMPLAINT TO DETERMINE WHERE THIS PRODUCT WAS USED AND SO (B)(4) ASSESSMENT FOR RISK IS DIFFICULT. (B)(4). MEDICAL AND CLINICAL REVIEWS CONDUCTED FOR SIMILARLY RELATED EVENTS HAVE CONCLUDED THAT THE WIPES PRODUCT IS LIKELY NOT THE ROOT CAUSE OF THE SYMPTOMS REPORTED IN THIS COMPLAINT. GIVEN THAT THIS IS AN ISOLATED INCIDENT WITH THIS LOT CODE AND THIS ISSUE, THERE IS NO OTHER CORRECTIVE ACTION WARRANTED ON THIS COMPLAINT.