MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-07 for LAP CHOLE PACK DYNJ35353D manufactured by Medline Industries, Inc..
[94112176]
Patient Sequence No: 1, Text Type: N, H10
[94112177]
Patient was in for a laparoscopic cholecystectomy and upon trying to use the co2 tubing, it was noticed that the tubing was not functioning properly. The gas flow was restricted and the co2 was not flowing. Tubing was exchanged for new one and problem was resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7095057 |
| MDR Report Key | 7095057 |
| Date Received | 2017-12-07 |
| Date of Report | 2017-11-02 |
| Date of Event | 2017-10-10 |
| Report Date | 2017-11-02 |
| Date Reported to FDA | 2017-11-02 |
| Date Reported to Mfgr | 2017-11-02 |
| Date Added to Maude | 2017-12-07 |
| 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 | LAP CHOLE PACK |
| Generic Name | LAPAROSCOPY KIT |
| Product Code | FDE |
| Date Received | 2017-12-07 |
| Model Number | DYNJ35353D |
| Catalog Number | DYNJ35353D |
| Lot Number | 17HK1420 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | 1204 TOWNLINE RD 1 MEDLINE PLACE MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-07 |