MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-02-28 for CARBON STEEL SAFETY SCALPEL #11 BA811SU manufactured by Aesculap Ag.
[139343829]
(b)(4). Manufacturing site evaluation: ongoing. If additional information is received a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[139343830]
It was reported when the #11 scalpel blade was opened, it was realized that it was rusted. The blade was not used. No additional information was provided. A request for additional information was made, however, not yet received. If additional information is provided a follow up report will be submitted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2019-00148 |
| MDR Report Key | 8380024 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-02-28 |
| Date of Report | 2019-04-03 |
| Date of Event | 2019-01-24 |
| Date Facility Aware | 2019-04-01 |
| Date Mfgr Received | 2019-04-01 |
| Device Manufacturer Date | 2018-08-06 |
| Date Added to Maude | 2019-02-28 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. NICOLE BROYLES |
| Manufacturer Street | 1 A RAUMANTIE |
| Manufacturer City | HELSINKI MO 00350 |
| Manufacturer Country | FI |
| Manufacturer Postal | 00350 |
| Manufacturer Phone | 3145515988 |
| Manufacturer G1 | AESCULAP AG |
| 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 | CARBON STEEL SAFETY SCALPEL #11 |
| Generic Name | DISPOSABLE SCALPELS |
| Product Code | GDX |
| Date Received | 2019-02-28 |
| Returned To Mfg | 2019-02-27 |
| Model Number | BA811SU |
| Catalog Number | BA811SU |
| Lot Number | 4509654778 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 5 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP AG |
| Manufacturer Address | PO BOX 40 TUTTLINGEN, 78501 GM 78501 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-28 |