MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-08 for MEDLINE RAYTECS BSC LAP SRG PROC DYNJ0604482AA manufactured by Medline Industries, Inc..
[174666345]
Raytec's from medline basic lap pack was falling apart before it was used on the pt. Raytecs from the pack were thrown off the field and new ones were used. No issues or harm to the pt. Filled out product failure sheet and notified management. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092122 |
| MDR Report Key | 9569529 |
| Date Received | 2020-01-08 |
| Date of Report | 2020-01-07 |
| Date of Event | 2019-12-30 |
| Date Added to Maude | 2020-01-09 |
| 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 |
| 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 | MEDLINE RAYTECS BSC LAP SRG PROC |
| Generic Name | LAPAROSCOPY KIT |
| Product Code | FDE |
| Date Received | 2020-01-08 |
| Model Number | DYNJ0604482AA |
| Catalog Number | DYNJ0604482AA |
| Lot Number | 19KKA041 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-08 |