ULTA-THIN PADS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-07-05 for ULTA-THIN PADS manufactured by Seventh Generation.

Event Text Entries

[17138406] Dirty waste paper in seventh generation's pad. Im a customer of "seventh generation, ultra-thin pads, chlorine free, regular with wings, 18 pads". On (b)(6), i opened one of their pads to use but found a piece of disgusting dirty waste paper in the middle of the folded pad. I've tried communicating with the company in the past month. They kept saying it's just a "mechanical error" and only agreed to refund for the pads but no compensation. I also expressed my concern that all the other pads of the same lot code had a chance to be polluted by the dirty waste paper as it went around among the naked pads before packing. The company replied slower and slower and finally stopped writing back 15 days ago. I have no choice but to come to you for help. Please let me know if you'd like to see to this. I'm able to provide the pad and dirty paper and all the corresponding emails if your need. Looking forward to your reply and help. Thank you very much.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	MW5030940
MDR Report Key	3239344
Date Received	2013-07-05
Date of Report	2013-07-03
Date Added to Maude	2013-07-23
Event Key	0
Report Source Code	Voluntary report
Manufacturer Link	N
Number of Patients in Event	0
Adverse Event Flag	3
Product Problem Flag	3
Reprocessed and Reused Flag	0
Reporter Occupation	PATIENT
Health Professional	0
Initial Report to FDA	3
Report to FDA	0
Event Location	0
Single Use	0
Previous Use Code	0
Event Type	3
Type of Report	3

Device Details

Brand Name	ULTA-THIN PADS
Generic Name	NONE
Product Code	HHL
Date Received	2013-07-05
Device Sequence No	1
Device Event Key	0
Manufacturer	SEVENTH GENERATION

Patients

Patient Number	Treatment	Outcome	Date
1	0		2013-07-05