MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2013-12-18 for L-CLIP PERM BAYONET 7 MM 45.748_EV manufactured by Peter Lazic Gmbh.
[4817982]
Report received from the usa stating that "package labeled as a 45. 748 actually contains 45. 744. " the device was not being used during surgery. No injury or medical intervention occurred. The date of event is unk. There was no additional info provided.
Patient Sequence No: 1, Text Type: D, B5
[12379736]
The device was received by (b)(4). (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
| Report Number | 1045834-2013-16099 |
| MDR Report Key | 3981072 |
| Report Source | 99 |
| Date Received | 2013-12-18 |
| Date of Report | 2011-08-31 |
| Date Facility Aware | 2011-08-31 |
| Report Date | 2011-08-31 |
| Date Added to Maude | 2014-08-06 |
| 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 | 3 |
| Manufacturer Street | 4500 RIVERSIDE DR. |
| Manufacturer City | PALM BEACH GARDENS FL 33410 |
| Manufacturer Country | US |
| Manufacturer Postal | 33410 |
| Manufacturer G1 | THE ANSPACH EFFORT, INC. |
| Manufacturer Street | 4500 RIVERSIDE DR. |
| Manufacturer City | PALM BEACH GARDENS FL 33410 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33410 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | L-CLIP PERM BAYONET 7 MM |
| Generic Name | NONE |
| Product Code | HCI |
| Date Received | 2013-12-18 |
| Returned To Mfg | 2011-09-08 |
| Catalog Number | 45.748_EV |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2013-12-18 |