MAUDE Adverse Event Report: AESCULAP AG ERGOPLANT ORAL SILICONE WEDGE #M; DENTAL

Model Number DX114

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with ergoplant oral silicone wedge.According to the complaint description there was a tear in hole.The complaint product is a new item.The tear was noticed during inspection when the customer received the product.No sample available.There was no patient harm.Additional information was not provided nor available.The malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation results: we did not receive the product for investigation, but two pictures were provided.The product does not require batch management; a review of the device quality and manufacturing history records is not possible.The failure is most probably supplier related.A product safety case (psc) has been opened for further evaluation.

• Brand Name: ERGOPLANT ORAL SILICONE WEDGE #M
• Type of Device: DENTAL
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10321149
• MDR Text Key: 207953009
• Report Number: 9610612-2020-00361
• Device Sequence Number: 1
• Product Code: DZN
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DX114
• Device Catalogue Number: DX114
• Device Lot Number: 4510894079
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/15/2020
• Initial Date FDA Received: 07/24/2020
• Supplement Dates Manufacturer Received: 08/03/2020
• Supplement Dates FDA Received: 09/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1