MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-12-04 for DYNJ55096B manufactured by Medline Industries.
[93627717]
It was reported that per the physician, the patient was removed from the surgical area after the unknown eye procedure was complete and it was noticed post-surgery that there was a small white fiber in the patient's lens. The eye had to be flushed to try and remove the lint, but the lint was unable to be flushed out. The patient was brought back into surgery to remove the lint from the lens. The surgeon reported that the product was inspected before use and no major fibers were noticed at that time. Per the surgeon, there was no permanent damage to the patient. The actual sample involved in the incident was not returned for evaluation. A number of attempts were made to obtain additional information, however the customer did not provide any additional information. There was no report of any additional adverse patient consequence and no effect on the patient's stability as a result of the incident. A sample has not been returned for evaluation however, due to the reported incident and subsequent need for surgical intervention, this medwatch is being filed. If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[93627718]
It was reported that a fiber got on a patients lens from the towel.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423395-2017-00028 |
| MDR Report Key | 7079747 |
| Report Source | USER FACILITY |
| Date Received | 2017-12-04 |
| Date of Report | 2017-12-04 |
| Date of Event | 2017-11-06 |
| Date Mfgr Received | 2017-11-06 |
| Date Added to Maude | 2017-12-04 |
| 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 DR |
| Manufacturer City | NORTHFIELD IL 60093 |
| Manufacturer Country | US |
| Manufacturer Postal | 60093 |
| Manufacturer Phone | 8476434960 |
| Manufacturer G1 | MEDLINE INDUSTRIES |
| Manufacturer Street | THREE LAKES DR |
| Manufacturer City | NORTHFIELD IL 60093 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60093 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | EYE PACK |
| Product Code | OJK |
| Date Received | 2017-12-04 |
| Catalog Number | DYNJ55096B |
| Lot Number | 17UB0822 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-12-04 |