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

Lot Number 3103243043W 01:26

Device Problem Insufficient Information (3190)

Patient Problems Genital Bleeding (4507); Unspecified Tissue Injury (4559)

Event Type  malfunction  

Event Description

Penis bleed [penile haemorrhage] case narrative: significant other reports that she made her boyfriends penis bleed due to retained tampon.No serious injury reported.

Manufacturer Narrative

There is insufficient information to perform an investigation.

Manufacturer Narrative

Product investigation is in progress.

Event Description

Hurt penis [penis injury] penis bleed [penile haemorrhage] case narrative: significant other reports that she made her boyfriends penis bleed due to retained tampon.No serious injury reported.

Event Description

Hurt penis [penis injury] penis bleed [penile haemorrhage] case narrative: significant other reports that she made her boyfriends penis bleed due to retained tampon.No serious injury reported.Correction: adverse event updated.

Manufacturer Narrative

There is insufficient information to perform an investigation.Correction: penis injury added as an adverse event.

Manufacturer Narrative

Product investigation is in progress.

Event Description

Hurt penis [penis injury] penis bleed [penile haemorrhage] case narrative: significant other reports that she made her boyfriends penis bleed due to retained tampon.No serious injury reported.Correction: adverse event updated.

• Brand Name: TAMPAXTAMPONSPEARLFULLSIZEULTRAUNSCNT
• 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: 17106482
• MDR Text Key: 316958677
• Report Number: 1219109-2023-00169
• Device Sequence Number: 1
• Product Code: HEB
• Combination Product (y/n): Y
• 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,Followup,Followup,Followup
• Report Date: 08/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Lot Number: 3103243043W 01:26
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No
• 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 Sex: Male