MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07,company representative, report with the FDA on 2015-05-14 for PROBE FOR CPMS 530.412 manufactured by Mipm Mammendorfer Institut Gmbh.
[5786281]
It was reported that the probe device had an error message? Probe malfunction with nine uses remaining. According to the report, the event occurred when the surgeon was checking a patient? S pressure. It was further reported that the surgeon did not use the device when he noticed the error message. There were no delays in the surgical procedure as a spare device was available for use. There was patient involvement reported. There were no injuries, medical intervention or prolonged hospitalization. All available information has been disclosed. If additional information should become available, a supplemental medwatch report will be submitted accordingly.
Patient Sequence No: 1, Text Type: D, B5
[13286929]
As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated. If additional information should become available, a supplemental medwatch report will be sent accordingly.
Patient Sequence No: 1, Text Type: N, H10
[31095182]
The manufacturer city was inadvertently documented as depuy synthes power tools. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2520274-2015-13493 |
| MDR Report Key | 4772883 |
| Report Source | 06,07,COMPANY REPRESENTATIVE, |
| Date Received | 2015-05-14 |
| Date of Report | 2015-04-14 |
| Date of Event | 2015-04-14 |
| Date Mfgr Received | 2015-10-23 |
| Device Manufacturer Date | 2012-06-22 |
| Date Added to Maude | 2015-06-15 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | N/I N/I |
| Manufacturer Street | F OSKAR-VON-MILLER STRASSE 6 |
| Manufacturer City | 82291 MAMMENDORF PA N/I |
| Manufacturer Country | GM |
| Manufacturer Postal | N/I |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | MIPM MAMMENDORFER INSTITUT GMBH |
| Manufacturer Street | OSKAR-VON-MILLER STR. 6 |
| Manufacturer City | MAMMENDORF |
| Manufacturer Country | GM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROBE FOR CPMS |
| Generic Name | MONITOR, PRESSURE, INTRACOMPARTMENT |
| Product Code | LXC |
| Date Received | 2015-05-14 |
| Catalog Number | 530.412 |
| Lot Number | US-21-1825 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MIPM MAMMENDORFER INSTITUT GMBH |
| Manufacturer Address | OSKAR-VON-MILLER STR. 6 MAMMENDORF GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-05-14 |