MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-17 for LAP SPONGE MDS251518LFT manufactured by Medline Industries, Inc..
[123988526]
Blue tail on lap sponge easily pulled out and away from sponge with potential to cause a retained sponge
Patient Sequence No: 1, Text Type: D, B5
Report Number | 7973892 |
MDR Report Key | 7973892 |
Date Received | 2018-10-17 |
Date of Report | 2018-09-30 |
Date of Event | 2017-11-14 |
Report Date | 2018-09-30 |
Date Reported to FDA | 2018-09-30 |
Date Reported to Mfgr | 2018-10-17 |
Date Added to Maude | 2018-10-17 |
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 SPONGE |
Generic Name | GAUZE/SPONGE, INTERNAL |
Product Code | EFQ |
Date Received | 2018-10-17 |
Catalog Number | MDS251518LFT |
Lot Number | 84317070128 |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Age | 1 DA |
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 | 2018-10-17 |