MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-11 for CATH GRIP/UNI GRIP 51300NS manufactured by Bioderm, Inc..
[108007759]
Patient Sequence No: 1, Text Type: N, H10
[108007760]
Catheter securement device new out of the package is ripping at the seam around the tabs. Cath grip 51300ns, lot do4403.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7506132 |
| MDR Report Key | 7506132 |
| Date Received | 2018-05-11 |
| Date of Report | 2018-05-07 |
| Date of Event | 2018-05-04 |
| Report Date | 2018-05-07 |
| Date Reported to FDA | 2018-05-07 |
| Date Reported to Mfgr | 2018-05-07 |
| Date Added to Maude | 2018-05-11 |
| 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 | CATH GRIP/UNI GRIP |
| Generic Name | ACCESSORIES, CATHETER |
| Product Code | KMK |
| Date Received | 2018-05-11 |
| Catalog Number | 51300NS |
| Lot Number | D04403 |
| Device Expiration Date | 2019-10-01 |
| Operator | NURSE |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIODERM, INC. |
| Manufacturer Address | 12320 73RD COURT NORTH LARGO FL 33773 US 33773 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-11 |