MAUDE Adverse Event Report: TAMBRANDS MANUFACTURING, INC TAMPAXTAMPONSPEARLFULLSIZESUPER,SUPERPLUS,ULTRAUNSCNT34CT; TAMPON, MENSTRUAL, UNSCENTED - HEB

Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Abdominal Cramps (2543); Cramp(s) /Muscle Spasm(s) (4521)
Type of Reportable Event	Malfunction
Event or Problem Description
Cramps stomach/(uterus area) [abdominal pain upper].(cramps stomach)/uterus area [uterine spasm].Defective.Seems like the core is unraveling [device breakage].Leaking- tampons [device ineffective].Case narrative: consumer reported via phone that the tampon core is unraveling.No serious injury was reported.
Additional Manufacturer Narrative
There is insufficient information to perform an investigation.

• Brand Name: TAMPAXTAMPONSPEARLFULLSIZESUPER,SUPERPLUS,ULTRAUNSCNT34CT
• Common Device Name: 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: 20078289
• Report Number: 1219109-2024-00294
• Device Sequence Number: 18067134
• Product Code: HEB
• UDI-Device Identifier: 00073010713383
• UDI-Public: (01)00073010713383
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/27/2024

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?: Yes
• Operator of Device: Lay User/Patient
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 25 YR
• Patient Sex: Female