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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HYGENIC DENTAL DAM THIN GREEN
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HYGENIC DENTAL DAM THIN GREEN Back to Search Results
Model Number H02146
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/29/2021
Event Type  Injury  
Event Description
The customer initially reported that the dental dam tears very quickly.It was confirmed on 07/08/2021 that the dental dam tore during treatment and that the root canal treatment had to be restarted.
 
Manufacturer Narrative
Investigation of returned product: typical values for freshly produced dental dam are tensile greater than or equal to 3,500 lbf/in² and ultimate elongation greater than or equal to 700% with reference to typical modulus at 100% elongation at 120 lbf/in².Properties will deteriorate as the dam ages.The mean value for tensile is 4,414 lbf/in² which is within specification for newly produced dental dam as well as ultimate elongation at 788% with 110 lbf/in² as the modulus at 100% lbf/in².From the data produced, it is determined that the dental dam is as expected and no abnormal results were found.The fit, form and function of the dam is not compromised.A review of past complaints was performed regarding tears for this sheeting lot from may 2019 until present.This is the first complaint recorded for this lot/part; therefore, no recurrence was identified.
 
Event Description
The customer initially reported that the dental dam tears very quickly.It was confirmed on (b)(6) 2021 that the dental dam tore during treatment and that the root canal treatment had to be restarted.The customer was contacted on (b)(6) 2021 to obtain additional information regarding any other medical devices that were being used at the time of the incident and to determine the number of patients that were affected.During this follow up, it was determined that an adverse event did not actually occur.The dentist indicated that the dental dam tore prior to procedure and was just providing an example of what could have happened if the dental dam would have torn during procedure (restart the root canal treatment).
 
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Brand Name
HYGENIC DENTAL DAM THIN GREEN
Type of Device
DENTAL DAM
MDR Report Key12377770
MDR Text Key268662428
Report Number2416455-2021-00004
Device Sequence Number1
Product Code EIE
UDI-Device IdentifierD661H021461
UDI-PublicD661H021461
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 04/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date11/17/2022
Device Model NumberH02146
Device Catalogue NumberH02146
Device Lot Number138K2
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/28/2021
Date Manufacturer Received08/27/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/18/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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