MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2014-06-24 for L-CLIP APPL/REMVR 90 MM RND HANDLE VAR 45.441 manufactured by Peter Lazic Gmbh.
[19397588]
The device was received by anspach. (b)(4) is the importer of the device. If additional info is received, a supplemental report will be sent. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[19483450]
Report received from the usa stating that the device's jaws would not close. It is unk if the event occurred during surgery, however, it is known that no injury or medical intervention was reported to have occurred. No additional info is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1045834-2013-16481 |
| MDR Report Key | 3931348 |
| Report Source | 99 |
| Date Received | 2014-06-24 |
| Date of Report | 2012-10-03 |
| Date of Event | 2012-10-02 |
| Date Facility Aware | 2012-10-03 |
| Report Date | 2012-10-03 |
| Date Added to Maude | 2014-07-15 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 | 0 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | L-CLIP APPL/REMVR 90 MM RND HANDLE VAR |
| Generic Name | NONE |
| Product Code | HCI |
| Date Received | 2014-06-24 |
| Catalog Number | 45.441 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PETER LAZIC GMBH |
| Manufacturer Address | TUTTLINGEN GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-06-24 |