MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-11 for LAP SPONGES MDS251504LF manufactured by Medline Industries, Inc..
[182962118]
Incorrect number of sponges in medline x-ray detectable gauze sponges pack. Baby laps ref # mds251504lf lot #26019070011 (packaging sent to central) issue: only 4 baby laps found upon opening/should be 5 xray detectable gauze sponges ref #non21430lf lot #6051901085 (will send packaging to risk) only 9 sponges found/should be 10.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9818618 |
| MDR Report Key | 9818618 |
| Date Received | 2020-03-11 |
| Date of Report | 2019-10-29 |
| Date of Event | 2019-10-22 |
| Report Date | 2020-02-11 |
| Date Reported to FDA | 2020-02-11 |
| Date Reported to Mfgr | 2020-03-11 |
| Date Added to Maude | 2020-03-11 |
| 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 |
| 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 | LAP SPONGES |
| Generic Name | GAUZE/SPONGE, INTERNAL |
| Product Code | EFQ |
| Date Received | 2020-03-11 |
| Catalog Number | MDS251504LF |
| Lot Number | 26019070011 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-11 |