FAST ABS DELUXE

Report

• Report Number: MW4003201
• Event Type: Injury
• Date Received: January 24, 2002
• Date of Event: January 18, 2002
• Report Date: January 24, 2002
• Manufacturer: UNK
• Product Code: IPF
• Adverse Event: Yes
• Report Source: Voluntary report
• Reporter Location: CA, US
• Reporter Occupation: PATIENT

Narratives

Description of Event or Problem · 1

CONSUMER APPLIED PALM SIZED DROP OF GEL TO THEIR STOMACH AND TO BASE OF MACHINE PER MFR'S INSTRUCTIONS. CONSUMER TURNED MACHINE TO "ON" POSITION, SET IT AT LEVEL "7" AND PLACED IT ON THE GEL ON THEIR STOMACH. APPROXIMATELY 10 MINS LATER CONSUMER NOTICED RED MARKS ON THEIR STOMACH (REASON WHY UNK). CONSUMER IMMEDIATELY DISCONTINUED USE OF AB MACHINE. THREE DAYS LATER CONSUMER CONTACTED MFR AT TEL# [phone] AND RECEIVED A BUSY SIGNAL. THE NEXT DAY CONSUMER CONTACTED MFR AT TEL#[phone] AND RECEIVED A BUSY SIGNAL. THE FOLLOWING DAY CONSUMER CONTACTED MFR AND EXPLAINED INCIDENT TO REP. REP OFFERED TO REFUND CONSUMER $80 PURCHASE PRICE. THE PRODUCT WAS NOT DAMAGED, REPAIRED OR MODIFIED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	FAST ABS DELUXE	BATTERY-OPERATED ELECTRONIC ABDOMINAL STRENGTHENING MACHINE	IPF	UNK	UNK	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	40 YR

Terms

Patient problem · 2

• Burning Sensation
• Erythema

Product problems · 1

• Reaction

Type of report · 1

• Initial submission