MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-31 for KERLIX BANDAGE ROLL 100% COTTON 6 PLY LARGE 4 1/2 X 4 1/8 YD 675 manufactured by Cardinal Health 200, Llc.
[119328246]
Kerlix bandage roll 100% cotton 6 ply large 4 1/2 x 4 1/8 yd, ref 675, lot 17g027762, upon opening, found to have a large piece of black taper/velcro entwined in the bandage.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5079544 |
| MDR Report Key | 7842414 |
| Date Received | 2018-08-31 |
| Date of Report | 2018-08-29 |
| Date of Event | 2018-08-13 |
| Date Added to Maude | 2018-09-04 |
| 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 |
| 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 | KERLIX BANDAGE ROLL 100% COTTON 6 PLY LARGE 4 1/2 X 4 1/8 YD |
| Generic Name | GAUZE / SPONGE, NON RESORBABLE |
| Product Code | NAB |
| Date Received | 2018-08-31 |
| Catalog Number | 675 |
| Lot Number | 17G027762 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH 200, LLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-31 |