MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-27 for ETHH12LP manufactured by Sterilmed, Inc..
[78556137]
Initial reporter: (b)(6). Contact office: (b)(4). The customer reported that the device was discarded and will not be returned for evaluation. The device history report was not reviewed as no lot number was provided.
Patient Sequence No: 1, Text Type: N, H10
[78556138]
It was reported that the device broke inside the patient without causing injury. Additional information has been requested but additional information was not received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134070-2017-00051 |
| MDR Report Key | 6671744 |
| Date Received | 2017-06-27 |
| Date of Report | 2017-06-05 |
| Date Mfgr Received | 2017-06-05 |
| Date Added to Maude | 2017-06-27 |
| 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 | SEAN FITZSIMMONS |
| Manufacturer Street | 5010 CHESHIRE PARKWAY SUITE 2 |
| Manufacturer City | PLYMOUTH MN 55446 |
| Manufacturer Country | US |
| Manufacturer Postal | 55446 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NA |
| Generic Name | LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED |
| Product Code | NLM |
| Date Received | 2017-06-27 |
| Model Number | ETHH12LP |
| Catalog Number | ETHH12LP |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERILMED, INC. |
| Manufacturer Address | 11400 73RD AVE N MAPLE GRV 55369 US 55369 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-27 |