FDA Adverse Event Injury Summary report: N

RITE AID TAMPON

MDR report key: 275738 · Received April 27, 2000

Report

Report Number
2529605-2000-00003
Event Type
Injury
Date Received
April 27, 2000
Date of Event
November 14, 1999
Report Date
April 4, 2000
Manufacturer
FIRST QUALITY HYGIENIC, INC.
Product Code
HEB
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
NY, US
Reporter Occupation
UNKNOWN

Narratives

Description of Event or Problem · 1

USER REPORTED THAT USER FELT A SCRATCH WHEN USER REMOVED A TAMPON. UPON EXAMINING THE TAMPON, USER SAW A STAPLE THAT APPEARED TO BE IN THE ORIGINAL UNUSED FORM, NOT BENT AS IF IT HAD BEEN USED. USER TOOK THE TAMPON TO THE ER AND SHOWED IT TO THE DR AND NURSE. USER REPORTS THAT USER HAS RECOVERED FULLY AND IS NOW OK. USER WENT TO THE RITE-AID STORE WHERE USER PURCHASED THE PRODUCT AND REPORTED IT TO THE MGR. THE MGR REPORTED THE INCIDENT TO THE CO'S INSURER. THE INSURANCE CO NOTIFIED FIRST QUALITY HYGIENIC, INC. RITE-AID HAS TWO SUPLIERS FOR PRIVATE LABEL TAMPONS. THE USER DISCARDED THE REMAINING TAMPONS AND CARTON. CO CANNOT BE CERTAIN THAT THE PRODUCT WAS MFG BY FQH, HOWEVER, THE USER SUBSEQUENTLY IDENTIFIED FQH PACKAGING AS THAT WHICH USER WAS USING WHEN THE INCIDENT OCCURRED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 RITE AID TAMPON VAGINAL TAMPON HEB FIRST QUALITY HYGIENIC, INC. OPEN END TAMPON UNK

Patients

Seq Age Sex Outcome Treatment
1 UNKNOWN Other