FDA Adverse Event Injury Summary report: N

IV PREP WIPES

MDR report key: 2174539 · Received July 24, 2011

Report

Report Number: 3006760724-2011-00005
Event Type: Injury
Date Received: July 24, 2011
Date of Event: April 13, 2011
Report Date: July 19, 2011
Manufacturer: SMITH & NEPHEW WOUND MANAGEMENT
Product Code: KMF
Removal / Correction Number: 3006760724-030211-001R
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: GA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

SMITH & NEPHEW WAS CONTACTED REGARDING THE ABOVE NAMED INCIDENT, WHICH WAS REPORTED AS A FIELD COMPLAINT FOR "SKIN IRRITATION/REACTION" AND "GENERAL ILLNESS". 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) AND CONTROL SAMPLES (FROM STOCK) OF LOT 0G249 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. MEDICAL ADVISOR REVIEWED THE EVENT DETAILS AND INDICATED THAT THERE IS NO MEDICAL EVIDENCE TO SUPPORT ANY RELATIONSHIP BETWEEN THE USE OF IV-PREP WIPES AND THE PATIENT'S SYMPTOMS.

Description of Event or Problem · 1

THIS IV 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 #3006760724-030211-001R). CUSTOMER WITH JUVENILE DIABETES, BEGAN WITH A SORE ON HER FACE NEAR TEMPLE, CURRENTLY HOSPITALIZED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	IV PREP WIPES	BANDAGE, LIQUID, SKIN PROTECTANT	KMF	SMITH & NEPHEW WOUND MANAGEMENT	59421200	0G249

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization