MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-06-26 for NG SECURE * 9304-1 manufactured by M. C. Johnson Co., Inc..
[20144382]
A nurse opened up an ng secure patch and the adhesive part was curling. The rn opened six more packs all of which had the same curling issue of the adhesive portion. All of the patches came out of the original packaging.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4894399 |
| MDR Report Key | 4894399 |
| Date Received | 2015-06-26 |
| Date of Report | 2015-06-26 |
| Date of Event | 2015-06-10 |
| Report Date | 2015-06-26 |
| Date Reported to FDA | 2015-06-26 |
| Date Reported to Mfgr | 2015-07-07 |
| Date Added to Maude | 2015-07-07 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NG SECURE |
| Generic Name | TUBE, NASOGASTRIC |
| Product Code | BSS |
| Date Received | 2015-06-26 |
| Model Number | * |
| Catalog Number | 9304-1 |
| Lot Number | 2357916 |
| ID Number | * |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | M. C. JOHNSON CO., INC. |
| Manufacturer Address | 8801 BUSINESS PARK DRIVE, SUIT FORT MYERS FL 33912 US 33912 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-06-26 |