MAUDE Adverse Event Report: 3M DEUTSCHLAND GMBH 3M CAPMIX; VACCUM MIXING DEVICE DENTAL

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Device Issue (2379); Human Factors Issue (2948)

Patient Problems Electric Shock (2554); Patient Problem/Medical Problem (2688)

Event Date 05/21/2018

Event Type  Injury  

Manufacturer Narrative

The capmix device is quite old and the on/off switch wasn't working properly any more.Instead of sending the device in for maintenance the husband of the nurse took the capmix home and tried to fix this by himself, which didn't work well and leaded to exposed contacts and subsequently to the injury.This was also confirmed by our internal analysis of the device.Therefore, there's clearly underlying a handling error.

Event Description

On (b)(6) 2018 it was reported to 3m (b)(4) that a capmix device caused an electric shock at a dental nurse, which leaded to numbness and feeling disorder in the right hand and arm.The nurse went to the doctor the same day after the accident.Our last information from (b)(6) was that the symptoms persist, but the nurse started to work again, so it can be assumed that the symptoms are not severe.However, the information about the latest status is not available to us.On (b)(6) 2018 it was reported to 3m (b)(4) that a capmix device caused an electric shock at a dental nurse, which leaded to numbness and feeling disorder in the right hand and arm.The nurse went to the doctor the same day after the accident.Our last information from (b)(6) was that the symptoms persist, but the nurse started to work again, so it can be assumed that the symptoms are not severe.However, the information about the latest status is not available to us.

• Brand Name: 3M CAPMIX
• Type of Device: VACCUM MIXING DEVICE DENTAL
• Manufacturer (Section D): 3M DEUTSCHLAND GMBH; carl-schurz-strasse 1; neuss, 41453 ; GM 41453
• Manufacturer (Section G): 3M DEUTSCHLAND GMBH; espeplatz 1; seefeld, 82229 ; GM 82229
• Manufacturer Contact: thomas meindl ; espeplatz 1; seefeld, 82229 ; GM 82229
• MDR Report Key: 7627730
• MDR Text Key: 111985405
• Report Number: 9611385-2018-00004
• Device Sequence Number: 1
• Product Code: EFD
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K891064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Dental Assistant
• Type of Report: Initial
• Report Date: 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dental Assistant
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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 Outcome(s): Other
• Patient Age: 44 YR