MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-04 for VAL011CTASA manufactured by Medline Industries Inc..
[132200545]
It was reported that during the post-operative evaluation of a patient, after an unidentified procedure, blue fibers were found in the patient's eye that the facility feels are coming from the back table cover. The facility reported that the event has occurred with eight patients. Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further patient, product, procedural, or retrieval details to the manufacturer. No sample has been received for evaluation. Due to the reported incident, and in an abundance of caution, this medwatch is being filed. If additional relevant information becomes available a supplemental medwatch will be filed. This is report six of eight.
Patient Sequence No: 1, Text Type: N, H10
[132200546]
It was reported that during the post-operative evaluation of a patient, after an unidentified procedure, blue fibers were found in the patient's eye.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423395-2018-00070 |
| MDR Report Key | 8218886 |
| Date Received | 2019-01-04 |
| Date of Report | 2019-01-04 |
| Date of Event | 2018-12-01 |
| Date Mfgr Received | 2018-12-13 |
| Date Added to Maude | 2019-01-04 |
| 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 | KAREN TRUTSCH |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 60093 |
| Manufacturer Country | US |
| Manufacturer Postal | 60093 |
| Manufacturer Phone | 8476434960 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Generic Name | CATARACT PACK |
| Product Code | OJK |
| Date Received | 2019-01-04 |
| Catalog Number | VAL011CTASA |
| Lot Number | 18IBM853 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES INC. |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-01-04 |