MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-04 for GYN LAPAROSCOPY LF CMPJ37661G manufactured by Medline Industries - Mundelein.
[177995124]
Sticker was placed on outside of gyn laparoscopy pack stating the one item on the inside has an exp of 10/31/2019 (betadine solution), but once removed from the inside of pack, the expiration date would then be 08/31/2020. In order to remove the betadine, the sterile pack would have to be opened completely to get the item. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092766 |
| MDR Report Key | 9671557 |
| Date Received | 2020-02-04 |
| Date of Report | 2020-01-31 |
| Date of Event | 2020-01-23 |
| Date Added to Maude | 2020-02-05 |
| 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 | 3 |
| Brand Name | GYN LAPAROSCOPY LF |
| Generic Name | GYNECOLOGICAL LAPAROSCOPIC KIT |
| Product Code | OHD |
| Date Received | 2020-02-04 |
| Catalog Number | CMPJ37661G |
| Lot Number | 19CB0737 |
| Device Expiration Date | 2019-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES - MUNDELEIN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-04 |