MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-07-28 for STEAM STER LOCKS ORANGE US906 manufactured by Aesculap Ag.
[50721631]
Manufacturing site investigation is on-going. Contract manufacturer (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[50721632]
Country of complaint: usa. Customer reported that following processing of sterilcontainers it was observed that the orange locks dots are changing back to blue. It has been stated that it is unknown if there are surgical delays related to this occurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916714-2016-00612 |
| MDR Report Key | 5831817 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-07-28 |
| Date of Report | 2016-07-28 |
| Date of Event | 2016-06-24 |
| Date Facility Aware | 2016-06-29 |
| Date Mfgr Received | 2016-06-29 |
| Date Added to Maude | 2016-07-28 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. 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 | 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 | STEAM STER LOCKS ORANGE |
| Generic Name | PROCESS INDICATOR LOCK |
| Product Code | KCT |
| Date Received | 2016-07-28 |
| Model Number | US906 |
| Catalog Number | US906 |
| Device Availability | * |
| 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 | 1. Other | 2016-07-28 |