MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-25 for PREMIUM WET SKIN PREP TRAY REORDER #DYND70660 manufactured by Medline Industries, Inc..
[121916906]
Package delivered from distributor (b)(4) on (b)(6) 2018. While opening package to remove contents, a live bug was seen crawling inside the sealed product. (medline sterile pack of premium wet skin prep).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5080119 |
| MDR Report Key | 7910367 |
| Date Received | 2018-09-25 |
| Date of Report | 2018-09-12 |
| Date of Event | 2018-09-12 |
| Date Added to Maude | 2018-09-26 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | PREMIUM WET SKIN PREP TRAY |
| Generic Name | SKIN PREP TRAY |
| Product Code | OJU |
| Date Received | 2018-09-25 |
| Catalog Number | REORDER #DYND70660 |
| Lot Number | 18EBE843 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | ONE MEDLINE PLACE MUDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-25 |