MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-27 for MEDLINE LAP CHOLE PACK DYNJ49351 manufactured by Medline Industries, Inc..
[131904338]
Medline lap chole pack #11 carbon steel blade extremely dull (could not cut skin). The defective blade was exchanged for a #11 stainless steel blade which functioned without issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5082672 |
| MDR Report Key | 8203179 |
| Date Received | 2018-12-27 |
| Date of Report | 2018-12-27 |
| Date of Event | 2018-12-24 |
| Date Added to Maude | 2018-12-28 |
| 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 | MEDLINE LAP CHOLE PACK |
| Generic Name | LAP CHOLE PACK |
| Product Code | FDE |
| Date Received | 2018-12-27 |
| Model Number | DYNJ49351 |
| Catalog Number | DYNJ49351 |
| Lot Number | 18JBJ674 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | NORTHFIELD IL 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-27 |