MAUDE Adverse Event Report: COLTENE WHALEDENT INC. HYGENIC; DENTAL DAM

Catalog Number H11627

Device Problems Material Integrity Problem (2978); Material Split, Cut or Torn (4008)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 06/04/2018

Event Type  malfunction  

Event Description

Dental dam tore in patients mouth after getting wet.

• Brand Name: HYGENIC
• Type of Device: DENTAL DAM
• Manufacturer (Section D): COLTENE WHALEDENT INC.; 235 ascot parkway; cuyahoga falls OH 44223
• MDR Report Key: 7808692
• MDR Text Key: 118246696
• Report Number: 2416455-2018-08237
• Device Sequence Number: 1
• Product Code: EIE
• UDI-Device Identifier: D661H116270
• UDI-Public: D661H116270
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 09/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: H11627
• Device Lot Number: 160J7
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1