MAUDE Adverse Event Report: HU-FRIEDY MFG CO.,LLC HU-FRIEDY; DENTAL PROBE

Model Number PCPMDBIU

Device Problems Bent (1059); Fracture (1260); Naturally Worn (2988)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  No Answer Provided  

• Brand Name: HU-FRIEDY
• Type of Device: DENTAL PROBE
• Manufacturer (Section D): HU-FRIEDY MFG CO.,LLC; 3232 n rockwell st; chicago IL 60618
• Manufacturer (Section G): HU-FRIEDY MFG CO.,LLC; 3232 n rockwell st; chicago IL 60618
• Manufacturer Contact: maria vrabie ; 3232 n rockwell st; chicago, IL 60618
• MDR Report Key: 5406601
• Report Number: 1416605-2016-00001
• Device Sequence Number: 1
• Product Code: EIX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dental Assistant
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2016
• Device Operator: Dentist
• Device Model Number: PCPMDBIU
• Device Catalogue Number: PCPMDBIU
• Device Lot Number: 0114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 91