MAUDE Adverse Event Report: HYGENIC DENTAL DAM THIN GREEN

Model Number	H02146
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2021
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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 or Problem 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).

• Brand Name: HYGENIC DENTAL DAM THIN GREEN
• Common Device Name: DENTAL DAM
• MDR Report Key: 12377770
• Report Number: 2416455-2021-00004
• Device Sequence Number: 17062230
• Product Code: EIE
• UDI-Device Identifier: D661H021461
• UDI-Public: D661H021461
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/17/2022
• Device Model Number: H02146
• Device Catalogue Number: H02146
• Device Lot Number: 138K2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2021
• Initial Date Received by Manufacturer: 07/08/2021
• Supplement Date Received by Manufacturer: 08/27/2021
• Initial Report FDA Received Date: 08/27/2021
• Supplement Report FDA Received Date: 09/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention