MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. DEROYAL ORTHO TANDEM 1200 ML SUCTION CANISTER; BOTTLE, COLLECTION, VACUUM

Model Number PHERDN-1200 B

Device Problem Crack (1135)

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

Event Date 11/04/2022

Event Type  malfunction  

Event Description

Deroyal ortho tandem 1200ml suction canister cracked entire length of the canister after low wall suction (-80 mm) applied.Fda safety report id# (b)(4).

• Brand Name: DEROYAL ORTHO TANDEM 1200 ML SUCTION CANISTER
• Type of Device: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.
• MDR Report Key: 15770960
• MDR Text Key: 303638299
• Report Number: MW5113204
• Device Sequence Number: 1
• Product Code: KDQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PHERDN-1200 B
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: JADA SYSTEM: (B)(6) 2022
• Patient Outcome(s): Other
• Patient Age: 24 YR
• Patient Sex: Male
• Patient Weight: 102 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White