MAUDE Adverse Event Report: HAGER & MEISINGER GMBH MASTER PIN WITH THREAD

Model Number 36BMP000010

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/03/2021

Event Type  Injury  

Manufacturer Narrative

The batch-related manufacturing documentation is inconspicuous and no other incidents of this type are known to have occurred at meisinger pins.Therefore, it can be assumed that there is no product defect.The risk of ingestion/aspiration of pin has already been considered with risk management and is reduced to a low probability of occurrence by corresponding information in the general application and safety instructions for the medical device produced by meisinger (state of the art to secure these devices e.G.By using a rubber dam).A remedial is not necessary.No article related problem could have been identified.Risk already considered and described in general application and safety instructions for the medical device produced by meisinger.No further incidents of this kind with meisinger pins.

Event Description

According to the doctor, a patient swallowed a pin.No further details about the incident have been provided.There are no information provided of remedial actions taken by the healthcare facility.The doctor did not provide any further information on the course of the incident.

• Brand Name: MASTER PIN WITH THREAD
• Type of Device: PIN
• Manufacturer (Section D): HAGER & MEISINGER GMBH; hansemannstr. 10; neuss, nordrhein-westfalen 41468 ; GM 41468
• Manufacturer (Section G): HAGER & MEISINGER GMBH; hansemannstr. 10; neuss, nordrhein-westfalen 41468 ; GM 41468
• Manufacturer Contact: eva schaffert ; hansemannstr. 10; neuss, nordrhein-westfalen 41468 ; GM 41468
• MDR Report Key: 13059182
• MDR Text Key: 282607013
• Report Number: 8010516-2021-00092
• Device Sequence Number: 1
• Product Code: DZL
• UDI-Device Identifier: E0HMMP101
• UDI-Public: +E0HMMP101/$C04115U
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K130682
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 12/22/2021

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
• Device Operator: Health Professional
• Device Model Number: 36BMP000010
• Device Lot Number: C04115
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female