MAUDE Adverse Event Report: PLAYTEX MANUFACTURING, INC. O.B. ORIGINAL SUPER PLUS UNSCENTED TAMPON; MENSTRUAL TAMPON, UNSCENTED

Lot Number 16047DC

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Edema (1820); Fever (1858); Chills (2191)

Event Date 08/16/2016

Event Type  Injury  

Event Description

Consumer reports she had edema with swollen legs following use of the product, plus fever and chills for three days.She states she went to an emergency room to seek care but she does not mention having received any medical treatment.

• Brand Name: O.B. ORIGINAL SUPER PLUS UNSCENTED TAMPON
• Type of Device: MENSTRUAL TAMPON, UNSCENTED
• Manufacturer (Section D): PLAYTEX MANUFACTURING, INC.; 805 walker rd; dover DE 19904
• Manufacturer (Section G): PLAYTEX MANUFACTURING, INC.; 805 walker rd; dover DE 19904
• Manufacturer Contact: gale lydic ; 185 saulsbury rd; dover, DE 19904 ; 3026786429
• MDR Report Key: 6069033
• MDR Text Key: 58842654
• Report Number: 2515444-2016-00012
• Device Sequence Number: 1
• Product Code: HEB
• UDI-Device Identifier: 7830007010
• UDI-Public: 7830007010
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K990536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 16047DC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/28/2016
• Initial Date FDA Received: 11/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other