FDA Adverse Event Injury Summary report: N

MASTER PIN WITH THREAD

MDR report key: 13059182 · Received December 22, 2021

Report

Report Number: 8010516-2021-00092
Event Type: Injury
Date Received: December 22, 2021
Date of Event: December 3, 2021
Report Date: December 22, 2021
Manufacturer: HAGER & MEISINGER GMBH
Product Code: DZL
UDI-DI: E0HMMP101
PMA / PMN Number: K130682
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: DENTIST
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

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.

Description of Event or Problem · 0

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.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1966682	MASTER PIN WITH THREAD	PIN	DZL	HAGER & MEISINGER GMBH	36BMP000010	C04115	E0HMMP101

Patients

Seq	Age	Sex	Outcome	Treatment
1		Female	Other