MAUDE Adverse Event Report: BLOCK DRUG CO., INC. POLIDENT DENTURE CLEANSER (UNKNOWN)

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Edema (1820); Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

A 1020379-2017-00075 is associated with argus case (b)(4), polident denture cleanser (unknown).

Event Description

Foreign body [foreign body in pharynx].Oedema mucosal [oedema mucosal].Case description: this case was reported by a physician via sales rep and described the occurrence of accidental ingestion of product in a (b)(6) -year-old female patient who received double salt denture cleanser (polident denture cleanser (unknown)) tablet for an unknown indication.On (b)(6) 2017 23:00, the patient started polident denture cleanser (unknown) (oral) 1 dosage form(s) single dose (1 dosage form(s) daily).In (b)(6) 2017, unknown after starting polident denture cleanser (unknown), the patient experienced oedema mucosal.On (b)(6) 2017 23:00, the patient experienced accidental ingestion of product, wrong product selected and foreign body in pharynx.The action taken with polident denture cleanser (unknown) was unknown.On an unknown date, the outcome of the accidental ingestion of product and wrong product selected were unknown and the outcome of the foreign body in pharynx and oedema mucosal were recovering/resolving.It was unknown if the reporter considered the foreign body in pharynx to be related to polident denture cleanser (unknown).The reporter considered the oedema mucosal to be related to polident denture cleanser (unknown).[clinical course].On (b)(6) 2017, around 23:00, the patient accidentally swallowed one tablet of polident denture cleanser (unknown) mistaking it for hypnotic.She noticed the error and tried to spit it out; however, because the tablet got stuck in pharynx, she consulted a physician.At the consultation, minor edema was noted in mucosa but no other symptom was noted.Because of her advanced age, she was placed on follow-up.Follow-up information received from the reporting physician on (b)(6) 2017.[clinical course].The patient was discharged from the hospital on the beginning of the following week.There was no further report.[reporter's comment].The reporting physician considered that minor mucosal edema was caused by polident denture cleanser (unknown).

• Brand Name: POLIDENT DENTURE CLEANSER (UNKNOWN)
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): BLOCK DRUG CO., INC.; 2149 harbor avenue; memphis TN 38113
• Manufacturer (Section G): GSK
• Manufacturer Contact: po box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 7045874
• MDR Text Key: 92586849
• Report Number: 1020379-2017-00075
• Device Sequence Number: 1
• Product Code: EFT
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial
• Report Date: 10/27/2017

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
• Device Operator: No Information
• Initial Date Manufacturer Received: 10/27/2017
• Initial Date FDA Received: 11/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 94 YR