POLIGRIP COMFORT STRIPS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,04 report with the FDA on 2015-06-23 for POLIGRIP COMFORT STRIPS manufactured by Kyowa, Ltd..

Event Text Entries

[6261445] Choked [choking]. Case description: this case was reported by a consumer via call center representative and described the occurrence of choked in a (b)(6) male pt who received polyethylene oxide, sodium carboxymethylcellulose (poligrip comfort strips) strip for an unk indication. The pt's past medical history included stroke. Concomitant products included medication unknown. In 2014, the pt started poligrip comfort strips. In 2014, an unk time after starting poligrip comfort strips, the pt experienced choked (serious criteria gsk medically significant). In 2014, the outcome of the choked was recovered/resolved. The reporter considered the choked to be related to poligrip comfort strips. The pt's wife reported that her husband was in a special care facility as he previously had a stroke. She stated that she purchased the poligrip comfort strips for the first time about a month ago (approximately (b)(6) 2014), and her husband choked on it when it was in his mouth. She reported that the product amount taken was "as directed". She reported that use of the product was discontinued, and the reaction resolved. She reported that the product was ot reintroduced. Follow-up was received on 10/28/2014. The reporter stated that the product was purchased in (b)(6) 2014, and one strip was used. The reporter stated that the pt was able to cough the strip up and the condition had subsided since the initial report. The reporter stated that the pt switched from strips to paste.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3004699328-2014-00011
• MDR Report Key: 4872074
• Report Source: 00,01,04
• Date Received: 2015-06-23
• Date of Report: 2014-10-06
• Date of Event: 2014-01-01
• Date Mfgr Received: 2014-10-06
• Date Added to Maude: 2015-07-01
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 0
• Manufacturer Street: PO BOX 13398
• Manufacturer City: RESEARCH TRIANGLE PARK NC 27709
• Manufacturer Country: US
• Manufacturer Postal: 27709
• Manufacturer Phone: 8888255249
• Manufacturer G1: GSK
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: POLIGRIP COMFORT STRIPS
• Generic Name: DENTURE ADHESIVE
• Product Code: KOL
• Date Received: 2015-06-23
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: KYOWA, LTD.
• Manufacturer Address: IZUMISANO FACTORY IZUMISANO-CITY, OSAKA JA

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2015-06-23