MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-30 for ETHMSM20 manufactured by Sterilmed, Inc..
[90545821]
The device has not yet been returned to the manufacturer at the time of this report. A supplemental form will be sent once the evaluation is completed if the device is returned. The device history report was unable to be reviewed as no lot number was obtained.
Patient Sequence No: 1, Text Type: N, H10
[90545822]
It was reported that the patient was taken to surgery for bilateral removal of expanders. The surgeon was clipping intraoperatively and said the reprocessed clip applier tore the patient's blood vessel. The operative note states the patient lost 300 cc's. The patient required transfusion of one unit of packed red blood cells. Her surgery was completed and she was transferred to the recovery room in good condition. Additional information has been requested, but no response has yet been received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134070-2017-00074 |
| MDR Report Key | 6986903 |
| Date Received | 2017-10-30 |
| Date of Report | 2017-10-25 |
| Date of Event | 2017-08-29 |
| Date Mfgr Received | 2017-08-29 |
| Date Added to Maude | 2017-10-30 |
| 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 | JAY ANDERSON |
| Manufacturer Street | 5010 CHESHIRE PARKWAY STE 2 |
| Manufacturer City | PLYMOUTH MN |
| Manufacturer G1 | STERILMED, INC. |
| Manufacturer Street | 5010 CHESHIRE PARKWAY STE 2 |
| Manufacturer City | PLYMOUTH |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NA |
| Generic Name | CLIP, IMPLANTABLE, REPROCESSED |
| Product Code | NMJ |
| Date Received | 2017-10-30 |
| Model Number | ETHMSM20 |
| Catalog Number | ETHMSM20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERILMED, INC. |
| Manufacturer Address | 5010 CHESHIRE PARKWAY STE 2 PLYMOUTH MN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-30 |