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 2017-07-12 for ETHH12LP manufactured by Sterilmed, Inc..
[79955545]
Contact with the customer concerning and a response was received indicating that the device will not be returned for an investigation. Should the complaint device ever be received in the future, this investigation may be reopened.
Patient Sequence No: 1, Text Type: N, H10
[79955546]
It was reported that a black piece broke off inside the patient. There was no injury to the patient. No packaging, information or device is available and therefore nothing will be returned for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134070-2017-00058 |
| MDR Report Key | 6708183 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-07-12 |
| Date of Report | 2017-07-12 |
| Date of Event | 2017-06-21 |
| Date Mfgr Received | 2017-06-21 |
| Date Added to Maude | 2017-07-12 |
| 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 |
| Manufacturer G1 | STERILMED, INC. |
| Manufacturer Street | 5010 CHESHIRE PARKWAY SUITE 2 |
| Manufacturer City | PLYMOUTH MN 55446 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 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 | 2017-07-12 |
| Model Number | ETHH12LP |
| Catalog Number | ETHH12LP |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERILMED, INC. |
| Manufacturer Address | 11400 73RD AVE. MAPLE GROVE MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-12 |