SKIN PREP WIPES 420400 GB420400

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2011-09-16 for SKIN PREP WIPES 420400 GB420400 manufactured by Smith & Nephew Wound Management.

Event Text Entries

[2199891] 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 has been in the hospital for 3 weeks with an encephalitis infection at the ostomy, which they feel may be related to the wipes.
Patient Sequence No: 1, Text Type: D, B5


[9290858] Active investigation in progress; results of investigation to be provided in a supplement report.
Patient Sequence No: 1, Text Type: N, H10


[18199387] The customer did not return any product. We were unable to confirm the complaint. Control samples (from stock) of lot 1a248 manufactured by triad were analyzed by an independent test laboratory and met finished product specifications with no microbial growth. An independent medical review concluded there was no correlation between the reported symptoms and the use of skin prep wipes. Batch records for the lot indicate all specifications were met at the time of release and no inconsistencies were noted.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3006760724-2011-00047
MDR Report Key2251031
Report Source08
Date Received2011-09-16
Date of Report2011-09-01
Date of Event2011-05-31
Date Mfgr Received2011-05-31
Date Added to Maude2011-09-16
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 Received2011-09-16
Model Number420400
Catalog NumberGB420400
Lot Number1A248
Device AgeDA
Device Eval'ed by MfgrR
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 2011-09-16

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