MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-29 for WOVEN GAUZE SPONGE 4 IN X 4 IN. NON21448 manufactured by Medline Industries, Inc..
[118882367]
Small brown spot noted on sterile gauze when it was removed from the packaging. No discoloration seen on the packaging.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5079480 |
| MDR Report Key | 7832213 |
| Date Received | 2018-08-29 |
| Date of Report | 2018-08-27 |
| Date of Event | 2018-08-19 |
| Date Added to Maude | 2018-08-30 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | WOVEN GAUZE SPONGE 4 IN X 4 IN. |
| Generic Name | GAUZE / SPONGE NONRESORBABLE FOR EXTERNAL USE |
| Product Code | NAB |
| Date Received | 2018-08-29 |
| Catalog Number | NON21448 |
| Lot Number | 6051710072 044 |
| 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 | MUNDELEIN IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-29 |