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

Catalog Number	H02146
Medical Device Problem Code	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	03/20/2018
Type of Reportable Event	Malfunction
Event or Problem Description
According to the dentist, the product breaks very easily and can not be used.Dam broke during procedure.
Additional Manufacturer Narrative
Customer states they received (1) box of h02146 dental dam, lot 191j1, that tears easily.The customer did not return any product for analysis.Complaint analysis: complaint history analysis shows no additional complaints for this batch.Inventory analysis shows no remaining product in stock of this lot number.Sap shows stock of this batch was depleted 01/25/2018.Root cause analysis: why? customer states product received tears easier than intended.Why? customer is dissatisfied with the material strength of the dental dam.Why? customer expectations do not meet final delivered product quality.Why? dental dam may have been heated/cooled during transportation or storage, weakening the material properties.Why? exposure to extreme temperatures (high/low) is known to accelerate deterioration and lower the shelf life of the product.The dental dam tore during procedure.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 DAM
• Manufacturer (Section D): COLTENE WHALEDENT INC.; 235 ascot parkway; cuyahoga falls OH 44223
• MDR Report Key: 7873960
• Report Number: 2416455-2018-09131
• Device Sequence Number: 1908372
• Product Code: EIE
• UDI-Device Identifier: D661H021461
• UDI-Public: D661H021461
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 09/28/2018

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 Expiration Date: 01/09/2021
• Device Catalogue Number: H02146
• Device Lot Number: 191J1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/09/2018
• Supplement Date Received by Manufacturer: 04/09/2018
• Initial Report FDA Received Date: 09/13/2018
• Supplement Report FDA Received Date: 09/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1