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 2017-07-11 for ETHH12LP manufactured by Sterilmed, Inc..
[79789521]
(b)(6). (b)(4). A response from the customer indicated that the device will not be returned for a full investigation. Should the complaint device(s) ever be received in the future, this investigation may be reopened.
Patient Sequence No: 1, Text Type: N, H10
[79789522]
Black piece broke off inside patient. No injury to the patient. Will not be returned for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134070-2017-00057 |
| MDR Report Key | 6703684 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-07-11 |
| Date of Report | 2017-07-11 |
| Date of Event | 2017-06-21 |
| Date Mfgr Received | 2017-06-21 |
| Date Added to Maude | 2017-07-11 |
| 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 STE 2 |
| Manufacturer City | PLYMOUTH 55446 |
| Manufacturer Country | US |
| Manufacturer Postal | 55446 |
| Manufacturer G1 | STERILMED, INC. |
| Manufacturer Street | 5010 CHESHIRE PARKWAY STE 2 |
| Manufacturer City | PLYMOUTH 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 | 2017-07-11 |
| Model Number | ETHH12LP |
| Catalog Number | ETHH12LP |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERILMED, INC. |
| Manufacturer Address | 11400 73RD AVE MAPLE GROVE MN 55369 US 55369 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-11 |