MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-16 for MEDLINE INDUSTRIES, INC. PHS747495000 manufactured by Medline Industries, Inc..
[67555704]
Patient Sequence No: 1, Text Type: N, H10
[67555705]
When opening for a case there was a hair found "woven into" a lap sponge. Manufacturer response for lap sponge: apologized and will send a replacement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6335246 |
| MDR Report Key | 6335246 |
| Date Received | 2017-02-16 |
| Date of Report | 2017-01-26 |
| Date of Event | 2017-01-04 |
| Report Date | 2017-01-04 |
| Date Reported to FDA | 2017-01-04 |
| Date Reported to Mfgr | 2017-01-04 |
| Date Added to Maude | 2017-02-16 |
| 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 | 3 |
| Brand Name | MEDLINE INDUSTRIES, INC. |
| Generic Name | LAP SPONGE |
| Product Code | EFQ |
| Date Received | 2017-02-16 |
| Catalog Number | PHS747495000 |
| Lot Number | 16UB5687 |
| Device Availability | * |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| 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 | 2017-02-16 |