MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-11-26 for BH LOU LAP CHOLE PACK LIGHT COVER DYNJ901847F manufactured by Medline Industries, Inc. -spt.
| Report Number | MW5091312 |
| MDR Report Key | 9383370 |
| Date Received | 2019-11-26 |
| Date of Report | 2019-11-25 |
| Date Added to Maude | 2019-11-27 |
| 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 | BH LOU LAP CHOLE PACK LIGHT COVER |
| Generic Name | LAPAROSCOPY KIT |
| Product Code | FDE |
| Date Received | 2019-11-26 |
| Catalog Number | DYNJ901847F |
| Lot Number | 19HBL909 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. -SPT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-11-26 |