MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-07 for CMC PEDIATRIC-LF DYNJ2218G manufactured by Medline Industries, Inc..
[72204285]
Patient Sequence No: 1, Text Type: N, H10
[72204286]
Punch hole piece of plastic was stuck to drape. It was not noticed until surgeon went to place drape on the patient. The drape was completely on the patient and stuck to them with the sticky edges when the surgeon noticed something odd on the edge of the opening of the drape. It was right above the umbilicus, surgeon thought it was hair on the field but when she looked closer, it was not hair. It looks like a hole punch of a piece of plastic.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6471816 |
| MDR Report Key | 6471816 |
| Date Received | 2017-04-07 |
| Date of Report | 2017-03-15 |
| Date of Event | 2017-02-24 |
| Report Date | 2017-03-15 |
| Date Reported to FDA | 2017-03-15 |
| Date Reported to Mfgr | 2017-03-15 |
| Date Added to Maude | 2017-04-07 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CMC PEDIATRIC-LF |
| Generic Name | TRAY, SURGICAL |
| Product Code | LRP |
| Date Received | 2017-04-07 |
| Model Number | DYNJ2218G |
| Lot Number | 16WB9592 |
| Device Availability | * |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | 1170 S NORTHPOINT BLVD. WAUKEGAN IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-07 |