MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-01 for CARING WOVEN STERILE GAUZE SPONGE PRM21448 manufactured by Medline Industries, Inc..
[122172817]
Caring 4 x 4 sterile gauze. When attempting to open the packaging using the opened tabs at the top of packaging, the package does not open cleanly. The paper shreds and peels in layers, but then the gauze is contaminated and you are unable to safely drop the gauze onto a sterile field. Manufacturer response for caring woven sterile gauze sponge, caring woven sterile gauze sponge (per site reporter). Our materials management dept returned the unused product to the manufacturer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7921816 |
| MDR Report Key | 7921816 |
| Date Received | 2018-10-01 |
| Date of Report | 2018-09-19 |
| Date of Event | 2018-07-09 |
| Report Date | 2018-09-19 |
| Date Reported to FDA | 2018-09-19 |
| Date Reported to Mfgr | 2018-10-01 |
| Date Added to Maude | 2018-10-01 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | CARING WOVEN STERILE GAUZE SPONGE |
| Generic Name | GAUZE / SPONGE,NONRESORBABLE FOR EXTERNAL USE |
| Product Code | NAB |
| Date Received | 2018-10-01 |
| Returned To Mfg | 2018-08-01 |
| Model Number | PRM21448 |
| Catalog Number | PRM21448 |
| Lot Number | 6051704013 039 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | 1204 TOWNLINE RD 1 MEDLINE PLACE MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-01 |