MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-07-30 for GIGLI WIRE SAW FINE 6-WIRES500MM FH415 manufactured by Aesculap Ag.
[23134727]
U. S. Reporting agent notified on: (b)(6) 2015. Manufacturing site evaluation.
Patient Sequence No: 1, Text Type: N, H10
[23134728]
Country of complaint: (b)(6). Inadequate quality of the material during first use. Metal shavings left in the wound, which caused artifacts during examination.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916714-2015-00651 |
| MDR Report Key | 4963922 |
| Date Received | 2015-07-30 |
| Date of Report | 2015-07-30 |
| Date Mfgr Received | 2015-05-27 |
| Device Manufacturer Date | 2015-03-01 |
| Date Added to Maude | 2015-08-04 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| 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 |
| Manufacturer Street | P.O BOX 40 |
| Manufacturer City | TUTTLINGEN |
| Manufacturer Country | GM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | GIGLI WIRE SAW FINE 6-WIRES500MM |
| Generic Name | CRANIAL SAW |
| Product Code | GDR |
| Date Received | 2015-07-30 |
| Model Number | FH415 |
| Catalog Number | FH415 |
| Lot Number | 52118162 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | I |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP AG |
| Manufacturer Address | TUTTLINGEN DE 78532 US 78532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-07-30 |