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

Catalog Number	H00750
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Material Integrity Problem (2978)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	05/29/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Dental dam is coming loose from frame.
Additional Manufacturer Narrative
Customer states they received (1) box of h00750 framed flexi-dam, lot 060j, that contains framed flexi-dam that is loose from the frame and ruptures when trying to put them in place.The customer did not return any product for analysis.Complaint analysis: complaint history analysis shows no additional complaints for the frame coming loose from this batch.The inventory analysis shows no remaining product in stock of this lot number.Sap shows stock of this batch, containing 2,280 boxes of, framed flexi-dam was depleted 06/07/2017.Root cause analysis: why? customer is dissatisfied with the adhesion of the flexi-dam to the frame.Why? the flexi-dam is separating from the edges of the frame.Why? poor adhesion is observed where the flexi-dam is glued to the frame.Why? a change in manufacturing process or materials by (b)(4) may be to blame for this change in adhesion properties.Why? it appears to be an isolated incident of a known issue that has been addressed through a capa generated internally at their facility by the supplier.Capa assessment: capa not required at this time.This lot will continue to be monitored for further occurrences.

• Brand Name: HYGENIC
• Common Device Name: DENTAL FRAMED DAM
• Manufacturer (Section D): COLTENE WHALEDENT INC.; 235 ascot parkway; cuyahoga falls OH 44223
• MDR Report Key: 7808766
• Report Number: 2416455-2018-08239
• Device Sequence Number: 2336437
• Product Code: EEF
• UDI-Device Identifier: D661H007500
• UDI-Public: D661H007500
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2018

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: H00750
• Device Lot Number: 060J
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/29/2018
• Supplement Date Received by Manufacturer: 05/29/2018
• Initial Report FDA Received Date: 08/23/2018
• Supplement Report FDA Received Date: 09/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1