MAUDE Adverse Event Report: ONTEX HYGIENEARTIKEL GMBH SEVENTH GENERATION; ORGANIC COTTON TAMPONS WITH COMFORT APPLICATOR- REGULAR ABSORBANCY

Model Number	REGULATORY ABSORBANCY
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/25/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
My wife and i have been loyal customers of seventh generation brand for 10+ years.Recently ((b)(6) 2018) my wife purchased "seventh generation organic cotton tampons with comfort applicator" from (b)(6) and tried to use it during the trip to (b)(6).But when she tried to take out the applicator from her body, the applicator got separated from plunger and remained inside her vagina.After several attempts to take it out of her body by ourselves, we needed to visit a local hospital at night and got helped from a gynecologist to take the plastic part out of her vagina.It was cost/time-consuming experience away in (b)(6) where my health insurance is not valid and the security is not so good as in the u.S., and emotionally very difficult as well.After the incident, we compared the sg tampon with one of the other brands' tampon and found out the other brand's applicator doesn't get separated when we pulled the plunger.Thus, i believe that the main reason of the unpleasant experience my family had is the bad design (easily separated) of seventh generation tampon product.I'd like to ask seventh generation to reimburse the cost we needed to pay and compensate what we needed to experienced.Please let me know how we can get reimbursed and compensation.

• Brand Name: SEVENTH GENERATION
• Common Device Name: ORGANIC COTTON TAMPONS WITH COMFORT APPLICATOR- REGULAR ABSORBANCY
• Manufacturer (Section D): ONTEX HYGIENEARTIKEL GMBH; fabrikstrasse 30; grosspostwitz sachsen, 96151 00; GM 9615100
• MDR Report Key: 7705814
• Report Number: 1648563-2018-00006
• Device Sequence Number: 13804278
• Product Code: HEB
• UDI-Device Identifier: 00732913451081
• UDI-Public: 00732913451081
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/18/2018
• Report Date (Section F): 07/20/2018

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: REGULATORY ABSORBANCY
• Device Catalogue Number: PLASTIC APPLICATOR
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Other
• Date Report to Manufacturer: 07/20/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 46 YR
• Date Report Sent to FDA: 07/20/2018