MAUDE Adverse Event Report: TAMBRANDS MANUFACTURING, INC TAMPAX TAMPON, VERSION/ABSORBENCY/SCENT UNKNOWN; TAMPON, MENSTRUAL, UNSCENTED

Lot Number NOT AVAILABLE

Device Problem Insufficient Information (3190)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  malfunction  

Manufacturer Narrative

There is insufficient information to perform a product investigation.

Event Description

Absorbing part stayed inside me - vagina [foreign body in reproductive tract].Pulled the string and the tampon broke / only the string came out, the absorbing part stayed inside [complication of device removal].Pulled the string and the tampon broke [device breakage].Consumer contacted via social media and stated that she pulled the string and the tampon broke; only the string came out, the absorbing part stayed inside her.No serious injury was reported.

• Brand Name: TAMPAX TAMPON, VERSION/ABSORBENCY/SCENT UNKNOWN
• Type of Device: TAMPON, MENSTRUAL, UNSCENTED
• Manufacturer (Section D): TAMBRANDS MANUFACTURING, INC; 2879 hotel rd; auburn, me
• Manufacturer (Section G): TAMBRANDS MANUFACTURING, INC; 2879 hotel rd; auburn, me
• Manufacturer Contact: regulatory feminine care ; winton hill business center; b6280 center hill avenue; cincinnati, oh
• MDR Report Key: 10483246
• MDR Text Key: 205323353
• Report Number: 1219109-2020-00262
• Device Sequence Number: 1
• Product Code: HEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081555
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: NOT AVAILABLE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/04/2020
• 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