MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2019-03-01 for CARBON STEEL SCALPEL BLADES #22 BB522 manufactured by Aesculap Ag.
[137539053]
(b)(4). When additional information is received a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[137539054]
It was reported that the closure was inappropriate not sterile. The closure of each peel packaging are inappropriate; thus, the scalpel blades are not sterile.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2019-00149 |
| MDR Report Key | 8382149 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-03-01 |
| Date of Report | 2019-03-01 |
| Date Facility Aware | 2019-02-26 |
| Date Mfgr Received | 2019-02-06 |
| Device Manufacturer Date | 2018-12-22 |
| Date Added to Maude | 2019-03-01 |
| 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 | 615 LAMBERT POINTE DR |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| 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 BLADES #22 |
| Generic Name | SCALPEL BLADES |
| Product Code | GES |
| Date Received | 2019-03-01 |
| Returned To Mfg | 2019-02-22 |
| Model Number | BB522 |
| Catalog Number | BB522 |
| Lot Number | 4509589491 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 4 YR |
| 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 | 2019-03-01 |