MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2015-09-10 for ETHMCM20 manufactured by Sterilmed, Inc..
[25498938]
The device was not returned to the manufacturer as of the date of this report. A supplemental report will be sent after the device evaluation if the device is received. No lot number was reported so the device history record could not be reviewed for discrepancies.
Patient Sequence No: 1, Text Type: N, H10
[25498939]
It was initially reported that the surgeon was complaining about the functionality of the device. Upon request for additional information, it was reported that after clips are released, the applier jaw got stuck to surrounding tissues and pulls tissue. There was no reported patient harm or injury. An new device was used to complete the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134070-2015-00044 |
| MDR Report Key | 5068300 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2015-09-10 |
| Date of Report | 2015-08-17 |
| Date Mfgr Received | 2015-08-19 |
| Date Added to Maude | 2015-09-10 |
| 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 | PATRICIA KAUFMAN |
| Manufacturer Street | 5010 CHESHIRE PARKWAY SUITE 2 |
| Manufacturer City | PLYMOUTH MN 55446 |
| Manufacturer Country | US |
| Manufacturer Postal | 55446 |
| Manufacturer Phone | 7634888321 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | CLIP, IMPLANTABLE, REPROCESSED |
| Product Code | NMJ |
| Date Received | 2015-09-10 |
| Model Number | ETHMCM20 |
| Catalog Number | ETHMCM20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERILMED, INC. |
| Manufacturer Address | 11400 73RD AVE N MAPLE GROVE MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-10 |