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 2019-02-20 for CARBON STEEL SCALPEL #11 BA211 manufactured by Aesculap Ag.
[136769036]
(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
[136769037]
It was reported that the blade was rusty after use on patient intraoperatively. It was reported that the #11 blade is showing signs of oxidation after use on the patient and when in contact with 0. 9% saline. No patient harm reported. Additional information has been requested, however, not yet received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2019-00111 |
| MDR Report Key | 8356122 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-02-20 |
| Date of Report | 2019-02-28 |
| Date of Event | 2019-01-19 |
| Date Facility Aware | 2019-02-12 |
| Date Mfgr Received | 2019-02-26 |
| Device Manufacturer Date | 2018-04-18 |
| Date Added to Maude | 2019-02-20 |
| 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 | 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 SCALPEL #11 |
| Generic Name | DISPOSABLE SCALPELS |
| Product Code | GDX |
| Date Received | 2019-02-20 |
| Model Number | BA211 |
| Catalog Number | BA211 |
| Lot Number | 4509374494 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 9 MO |
| Device Eval'ed by Mfgr | R |
| 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 | 2019-02-20 |