MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-05-11 for FIXODENTDENTURECAREDENTUREADHESIVEEXTSUPERHOLDPWDNOFLAVORSCENT2.7OZ manufactured by Procter & Gamble Manufacturing Co..
[74916991]
Return of product has been requested. Product and complete lot number not provided by reporter, therefore unable to proceed with product investigation at this time. Full evaluation will occur upon receipt of returned product.
Patient Sequence No: 1, Text Type: N, H10
[74916992]
Unable to drink and eat/no nutrition for a week [feeding disorder]; choked during swallowing evaluation [dysphagia]; health declined [general physical health deterioration]; pain - towards the back of the mouth and roof of mouth [oral pain]; skin pulled off - towards the back of the mouth and roof of mouth [mouth injury]; choking [choking]; sores - toward back of the mouth [stomatitis]; had the adhesive towards the back of his throat and back of mouth, had to be removed - fixodent [foreign body]; had adhesive towards back of throat and back of his mouth, was choking, had to have removed and caused pain and skin being pulled off - fixodent [injury associated with device]; caregivers at the facility applied additional fixodent to her father's dentures [device use issue]. Case description: a daughter reported via phone on 21-apr-2017 that her (b)(6) father's dentures were not staying in well so upon a family member's recommendation she and her sister purchased and applied fixodent denture care denture adhesive extra-super hold powder no flavor-scent 2. 7oz 1/4 teaspoon application each evening to his dentures at night so that he could have them in all day the next day. She and her sister would go to the facility that cared for her father and apply the fixodent. She asserted that one of the caregivers at the facility applied additional fixodent to her father's dentures. One morning on an unspecified date, her father choked while eating his breakfast and he was sent to the emergency room. According to the daughter, she and her sister did not know what was going on, but when he was seen in the emergency room they discovered he had the adhesive towards the back of his throat and mouth. The doctor stated that whatever was at the back of his throat and mouth had to removed, and a nurse started removing the product. While she was removing the product, her father experienced pain, some of the skin was pulled off during removal, and sores developed. Once the product was removed from his mouth, the daughter recalled asking the doctor if any more of the product could have made its way farther down her father's throat and the doctor assured her that the product had been removed. Her father stayed in the hospital for a week; the doctor advised that they had to try and get their father to eat and drink. Her father had a swallowing evaluation with thickened cranberry juice and he choked. Additional treatment included intravenous fluids. After a week of attempting to get her father to eat and drink, it was decided a peg (percutaneous endoscopic gastrostomy) tube was needed. The surgeon attempted to intubate her father and could not get the endotracheal tube down her father's throat. The surgeon removed fixodent product from his throat and her father was eventually able to get the peg tube. According to the daughter, sometime later her father was discharged back to the facility where he remained until he passed away over a year ago. The daughter clarified that it seemed once he was discharged from the hospital his health declined. The daughter believed the decline in his health occurred as a result of her father not having any nutrition for a week. Relevant medical history included: drug allergies to penicillin and other unspecified medications. Her father had good days and bad days; some days he was able to communicate and other days he was unable to do so. The main reason for the daughter's call was to explain that the product should be labeled better with a warning for individuals like her father who cannot always communicate what they are experiencing. Concomitant product(s): none reported. The case outcome was fatal. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1530449-2017-00003 |
| MDR Report Key | 6559802 |
| Report Source | CONSUMER |
| Date Received | 2017-05-11 |
| Date of Report | 2017-04-21 |
| Date Mfgr Received | 2017-04-21 |
| Date Added to Maude | 2017-05-11 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MGR. REGULATORY ORAL CARE |
| Manufacturer Street | 8700 MASON MONTGOMERY ROAD |
| Manufacturer City | MASON OH 45040 |
| Manufacturer Country | US |
| Manufacturer Postal | 45040 |
| Manufacturer G1 | PROCTER & GAMBLE MANUFACTURING CO. |
| Manufacturer Street | 6200 BRYAN PARK ROAD |
| Manufacturer City | BROWN SUMMIT NC 27214 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27214 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FIXODENTDENTURECAREDENTUREADHESIVEEXTSUPERHOLDPWDNOFLAVORSCENT2.7OZ |
| Generic Name | ADHESIVE, DENTURE |
| Product Code | KOO |
| Date Received | 2017-05-11 |
| Lot Number | NOT AVAILABLE |
| ID Number | NOT AVAILABLE |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PROCTER & GAMBLE MANUFACTURING CO. |
| Manufacturer Address | 6200 BRYAN PARK ROAD BROWN SUMMIT NC 27214 US 27214 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Hospitalization | 2017-05-11 |