MAUDE Adverse Event Report: TAMBRANDS MANUFACTURING, INC TAMPAXTAMPONSPEARLCOMPAKPEARLCOMPAKSUPERNONDO18CT; TAMPON, MENSTRUAL, UNSCENTED - HEB

Lot Number 2127208001 23:23

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Discomfort (2330); Foreign Body In Patient (2687)

Event Type  malfunction  

Event Description

Tampon got stuck-vagina [foreign body in reproductive tract].Vaginal discomfort [vulvovaginal discomfort].Abdominal pain [abdominal pain].String came out [device breakage].Case narrative: consumer's mother reported that the tampon string broke and became stuck in her daughter's vagina.No serious injury was reported.

Manufacturer Narrative

No manufacturing cause identified based on investigation.

Manufacturer Narrative

Correction: product name no failure could be identified as a result of the investigation.

Event Description

Tampon got stuck-vagina [foreign body in reproductive tract] vaginal discomfort [vulvovaginal discomfort] abdominal pain [abdominal pain] string came out [device breakage] case narrative: consumer's mother reported that the tampon string broke and became stuck in her daughter's vagina.No serious injury was reported.

• Brand Name: TAMPAXTAMPONSPEARLCOMPAKPEARLCOMPAKSUPERNONDO18CT
• Type of Device: TAMPON, MENSTRUAL, UNSCENTED - HEB
• Manufacturer (Section D): TAMBRANDS MANUFACTURING, INC; 2879 hotel rd; auburn 04210
• Manufacturer (Section G): TAMBRANDS MANUFACTURING, INC; 2879 hotel rd; auburn 04210
• Manufacturer Contact: manager affairs,feminine care ; winton hill business center b; 6280 center hill avenue; cincinnati 45224
• MDR Report Key: 15303039
• MDR Text Key: 302852956
• Report Number: 1219109-2022-00355
• Device Sequence Number: 1
• Product Code: HEB
• Combination Product (y/n): Y
• Reporter Country Code: UK
• PMA/PMN Number: K133244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 2127208001 23:23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 15 YR
• Patient Sex: Female