MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-26 for DYNJP4001 manufactured by Medline Industries Inc..
[128390645]
It was reported that during a mitral valve repair, the drape shed foam into the surgical site. The physician was required to remove the foam material from the surgical site with suction and forceps. The patient was under general anesthesia at the time of the incident. The procedure did not last longer than expected and the patient did not require additional anesthesia. No impact to the patient or the patient's stability was reported to the manufacturer. Reportedly, the drape involved in this incident was discarded. No sample was returned to the manufacturer for evaluation. A root cause for the reported incident could not be determined. Due to the reported incident and the need for medical intervention to remove the foam material from the surgical site, 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
[128390646]
It was reported that during a mitral valve repair, the drape shed foam into the surgical site.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423395-2018-00060 |
| MDR Report Key | 8102509 |
| Date Received | 2018-11-26 |
| Date of Report | 2018-11-26 |
| Date of Event | 2018-11-08 |
| Date Mfgr Received | 2018-11-12 |
| Date Added to Maude | 2018-11-26 |
| 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 | DRAPE,CV,UNFENESTRATED,STERILE |
| Product Code | PUI |
| Date Received | 2018-11-26 |
| Catalog Number | DYNJP4001 |
| Lot Number | 45018070267HJ |
| 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 600932753 US 600932753 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-11-26 |