MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2014-02-19 for YASARGIL TEMP MINI-CLIP STR 7MM FE721K manufactured by Aesculap Ag And Co. Kg.
[16182703]
Country of complaint: (b)(6). During placement of the clip at the aneurysm, it did not completely close. Clip was removed and replaced by a functional clip.
Patient Sequence No: 1, Text Type: D, B5
[16315003]
(b)(4). Us reporting agent notified on (b)(4) 2014. Mfg site eval: all permanent clips are tested regarding their closing force. The date of the affected batch was reviewed and found to be fully according to the specifications. There are no hints for material or product deviations.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2916714-2014-00092 |
| MDR Report Key | 3883155 |
| Report Source | 01,07 |
| Date Received | 2014-02-19 |
| Date of Report | 2014-02-17 |
| Date of Event | 2014-11-10 |
| Date Mfgr Received | 2013-11-13 |
| Device Manufacturer Date | 2013-09-01 |
| Date Added to Maude | 2014-07-07 |
| 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 | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHELLE LINK |
| Manufacturer Street | 615 LAMBERT POINTE DR. |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3145515938 |
| Manufacturer G1 | AESCULAP AG AND CO. KG |
| Manufacturer Street | PO BOX 40 |
| Manufacturer City | TUTTLINGEN 78501 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | YASARGIL TEMP MINI-CLIP STR 7MM |
| Product Code | HCH |
| Date Received | 2014-02-19 |
| Model Number | FE721K |
| Catalog Number | FE721K |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP AG AND CO. KG |
| Manufacturer Address | TUTTLINGEN DE 78532 US 78532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-02-19 |