MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2015-01-21 for AVM MICROCLIP PHYNOX STRAIGHT 2MM FE902K manufactured by Aesculap Ag & Co. Kg.
[5181615]
Country of complaint: (b)(6). Blades crossing over. It is unk if there was surgical delay.
Patient Sequence No: 1, Text Type: D, B5
[12782054]
Us reporting agent notified on: (b)(6) 2015. Manufacturing site evaluation: product was not returned for evaluation. Clips are 100 percent tested during production. Production failure is excluded. No root cause can be determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2916714-2015-00047 |
| MDR Report Key | 4459121 |
| Report Source | 01,07 |
| Date Received | 2015-01-21 |
| Date of Report | 2015-01-20 |
| Date Mfgr Received | 2014-03-08 |
| Date Added to Maude | 2015-02-20 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | NICOLE BROYLES |
| Manufacturer Street | 615 LAMBERT POINTE DRIVE |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3145515988 |
| Manufacturer G1 | AESCULAP AG & 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 | AVM MICROCLIP PHYNOX STRAIGHT 2MM |
| Generic Name | ANEURYSM CLIP |
| Product Code | HCH |
| Date Received | 2015-01-21 |
| Model Number | FE902K |
| Catalog Number | FE902K |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP AG & CO. KG |
| Manufacturer Address | TUTTLINGEN, DE 78532 GM 78532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-01-21 |