MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-21 for 3M CAPMIX manufactured by 3m Deutschland Gmbh.
[111985405]
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.
Patient Sequence No: 1, Text Type: N, H10
[111985406]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611385-2018-00004 |
| MDR Report Key | 7627730 |
| Date Received | 2018-06-21 |
| Date of Report | 2018-05-22 |
| Date of Event | 2018-05-21 |
| Date Mfgr Received | 2018-05-22 |
| Date Added to Maude | 2018-06-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | DENTAL ASSISTANT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DR THOMAS MEINDL |
| Manufacturer Street | ESPEPLATZ 1 |
| Manufacturer City | SEEFELD, 82229 |
| Manufacturer Country | GM |
| Manufacturer Postal | 82229 |
| Manufacturer G1 | 3M DEUTSCHLAND GMBH |
| Manufacturer Street | ESPEPLATZ 1 |
| Manufacturer City | SEEFELD, 82229 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 82229 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | 3M CAPMIX |
| Generic Name | VACCUM MIXING DEVICE DENTAL |
| Product Code | EFD |
| Date Received | 2018-06-21 |
| Returned To Mfg | 2018-06-15 |
| Operator | DENTAL ASSISTANT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M DEUTSCHLAND GMBH |
| Manufacturer Address | CARL-SCHURZ-STRASSE 1 NEUSS, 41453 GM 41453 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-06-21 |