MAUDE Adverse Event Report: EDGEWELL PERSONAL CARE CANADA ULC O.B. ORIGINAL REGULAR; MENSTRUAL TAMPON

Device Problem Entrapment of Device (1212)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Event Description

Consumer reported that a piece of the plastic film was stuck on the top of the tampon which was inserted into her vagina causing infection and a few days in the hospital.Although no medical records have been received, edgewell is reporting this case because the consumer stated she was hospitalized with an infection.

• Brand Name: O.B. ORIGINAL REGULAR
• Type of Device: MENSTRUAL TAMPON
• Manufacturer (Section D): EDGEWELL PERSONAL CARE CANADA ULC; 800 12th street; hanover, ont N4N 0 B1; CA N4N 0B1
• Manufacturer (Section G): PLAYTEX PRODUCTS, INC.; 50 north dupont hwy.; dover DE 19904
• Manufacturer Contact: 50 north dupont hwy.; dover, DE 19904
• MDR Report Key: 5246113
• MDR Text Key: 32120141
• Report Number: 2515444-2015-00003
• Device Sequence Number: 1
• Product Code: HEB
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/14/2015
• Event Location: Home
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization