MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-06 for DYNJP2492 manufactured by Medline Industries Inc..
[107587206]
It was reported that during an unidentified procedure, the blue foam on the drape shred off of the drape and fell into the surgical site. 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.
Patient Sequence No: 1, Text Type: N, H10
[107587207]
It was reported that during an unidentified procedure, the blue foam on the drape shred off of the drape and fell into the surgical site.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423395-2018-00024 |
| MDR Report Key | 7489595 |
| Date Received | 2018-05-06 |
| Date of Report | 2018-05-06 |
| Date of Event | 2018-04-01 |
| Date Mfgr Received | 2018-04-13 |
| Date Added to Maude | 2018-05-06 |
| 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,MINOR PROC,6X6 FEN, STER |
| Product Code | PUI |
| Date Received | 2018-05-06 |
| Catalog Number | DYNJP2492 |
| Lot Number | (10)39917100010 |
| 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. Other | 2018-05-06 |