MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-30 for DYNJ50948 manufactured by Medline Industries Inc..
[125641964]
It was reported that during an unidentified ophthalmic procedure, fibers from an unidentified component were found to have fallen into the patient's eye. The facility was contacted and was unable to identify if the fibers came from a gown or an operating room towel. The facility noted that there was no patient impact related to this incident and that they are unable or unwilling to provide any additional patient, product, or procedural information. It was not identified which eye the fibers fell on. It was not identified how the fibers were retrieved. No procedural impact, serious injury, or follow-up care was originally reported to the manufacturer. A sample of unopened operating room towels was returned to the manufacturer and lint was noted on the operating room towels only. It is unknown how the operating room towels were used during the procedure. No sample of a gown was returned to the manufacturer for evaluation. It is unknown at what point in the procedure the fibers were identified. A root cause for the reported incident could not be determined. 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.
Patient Sequence No: 1, Text Type: N, H10
[125641965]
It was reported that during an unidentified ophthalmic procedure, fibers from an unidentified component were found to have fallen into the patient's eye.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423395-2018-00057 |
| MDR Report Key | 8019476 |
| Date Received | 2018-10-30 |
| Date of Report | 2018-10-30 |
| Date of Event | 2018-10-01 |
| Date Mfgr Received | 2018-10-16 |
| Date Added to Maude | 2018-10-30 |
| 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 | NIGEL VILCHES |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 600932753 |
| Manufacturer Country | US |
| Manufacturer Postal | 600932753 |
| Manufacturer Phone | 2249311458 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Generic Name | CATARACT PACK |
| Product Code | OJK |
| Date Received | 2018-10-30 |
| Returned To Mfg | 2018-10-25 |
| Catalog Number | DYNJ50948 |
| Lot Number | 18NB3371 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES INC. |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 600932753 US 600932753 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2018-10-30 |