MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-19 for MULTI CLIP APPLIER LIGACLIP SMALL CLIPS ETHMCS20 manufactured by Sterilmed, Inc..
[114538374]
Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made. As such, the investigation will be closed. If the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate. We are working on the device history record (dhr), once we get more information it will be submitted in a supplemental. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[114538375]
A user facility report was received from the fda that reported a clip applicator was not firing properly as the clips were not loading up and firing. In addition, on the user facility, the event type of serious injury was checked and event outcome of required intervention was also checked. However, there was no further information on this serious injury as well as no contact information to gain further clarification. Therefore, to be conservative sterilmed is reporting this event as a bleeding event as that is our assumption of the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134070-2018-00105 |
| MDR Report Key | 7705090 |
| Date Received | 2018-07-19 |
| Date of Report | 2018-06-21 |
| Date of Event | 2018-06-06 |
| Date Mfgr Received | 2018-06-21 |
| Device Manufacturer Date | 2017-11-10 |
| Date Added to Maude | 2018-07-19 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. GABRIEL ALFAGEME |
| Manufacturer Street | 5010 CHESHIRE PARKWAY STE 2 |
| Manufacturer City | PLYMOUTH MN 55446 |
| Manufacturer Country | US |
| Manufacturer Postal | 55446 |
| Manufacturer Phone | 7634883200 |
| 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 | 0 |
| Brand Name | MULTI CLIP APPLIER LIGACLIP SMALL CLIPS |
| Generic Name | CLIP, IMPLANTABLE, REPROCESSED |
| Product Code | NMJ |
| Date Received | 2018-07-19 |
| Catalog Number | ETHMCS20 |
| Lot Number | 2029384 |
| Device Expiration Date | 2018-11-10 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 55446 US 55446 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-07-19 |