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.
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