MAUDE Adverse Event Report: APPLICATOR; APPLICATOR FOR RECTAL SUPPOSITORY

Device Problems Improper Flow or Infusion (2954); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/10/2022

Event Description

Reporter called report anucort 25 mg suppository.She states she had a hard time pushing the content out as it was tight.

• Brand Name: APPLICATOR
• Type of Device: APPLICATOR FOR RECTAL SUPPOSITORY
• MDR Report Key: 15563168
• MDR Text Key: 301554913
• Report Number: MW5112502
• Device Sequence Number: 1
• Product Code: OOW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1
• Patient Age: 92 YR
• Patient Sex: Female