SKIN-PREP WIPES 420400

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 SKIN-PREP WIPES 420400 manufactured by Smith & Nephew Wound Management.

Event Text Entries

[9575333] We were unable to confirm the complaint based on inspection of the returned samples, hence laboratory testing was performed. The returned samples of lot 0f164 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 skin prep wipes.
Patient Sequence No: 1, Text Type: N, H10


[14964735] This skin prep 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 in the hospital for five days at monroe hospital. Patient states his temperature was 105. Patient diagnosed with having e-coli greater than 100, 000. Patient also had an infusion.
Patient Sequence No: 1, Text Type: D, B5


[15169884] Active investigation in progress; results of investigation will be provided in a supplement report. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3006760724-2011-00024
MDR Report Key2218236
Report Source04
Date Received2011-08-22
Date of Report2011-08-19
Date of Event2011-08-09
Date Facility Aware2011-08-09
Date Mfgr Received2011-08-09
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 Professional3
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 NameSKIN-PREP WIPES
Generic NameBANDAGE, LIQUID, SKIN PROTECTANT
Product CodeNEC
Date Received2011-08-22
Model Number420400
Lot Number0F164
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSMITH & NEPHEW WOUND MANAGEMENT
Manufacturer Address970 LAKE CARILLON DRIVE SUITE 110 ST. PETERSBURG FL 33716 US 33716


Patients

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.