UNISOLVE WIPES 402300

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2011-08-22 for UNISOLVE WIPES 402300 manufactured by Smith & Nephew Wound Management.

Event Text Entries

[2167779] 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). In (b)(6) had a urinary tract infection. Went to dr. For medicine on (b)(6), thought it was cleared up. Admitted to hospital (b)(6) for congestive heart failure and nurses found urinary tract infection still present.
Patient Sequence No: 1, Text Type: D, B5


[9258356] Smith & nephew was contacted regarding the above described incident, which was reported as a field complaint for "infection-general/systemic". The customer sent in some product samples. We were unable to confirm the complaint based on inspection of the returned samples, hence laboratory testing was performed. Both the returned sample(s) of lot 0f198 and control samples of additional lots (from stock) 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 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.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3006760724-2011-00020
MDR Report Key2218270
Report Source04
Date Received2011-08-22
Date of Report2011-04-28
Date of Event2011-04-28
Date Mfgr Received2011-04-28
Date Added to Maude2011-08-22
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactMR TERRY MCMAHON
Manufacturer Street970 LAKE CARILLON DRIVE SUITE 110
Manufacturer CityST. PETERSBURG FL 33716
Manufacturer CountryUS
Manufacturer Postal33716
Manufacturer Phone7273993785
Manufacturer G1SMITH & NEPHEW WOUND MANAGEMENT
Manufacturer Street970 LAKE CARILLON DRIVE SUITE 110
Manufacturer CityST. PETERSBURG FL 33716
Manufacturer CountryUS
Manufacturer Postal Code33716
Single Use0
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUNISOLVE WIPES
Generic NameSOLVENT, ADHESIVE TAPE
Product CodeKOX
Date Received2011-08-22
Model Number402300
Catalog Number402300
Lot Number0F198
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerSMITH & NEPHEW WOUND MANAGEMENT
Manufacturer Address970 LAKE CARILLON DRIVE SUITE 110 ST. PETERSBURG FL 33176 US 33176


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Other 2011-08-22

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