MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-10-25 for DYKQSL3C manufactured by Medline Industries Inc.
[58325845]
Customer reported during a diagnostic laparoscopic surgery, with a cholecystectomy and ventral hernia repair, the patient was placed in reverse trendelenburg with left side slightly air planed down. The patient was secured to the table with foam arm padding and thigh safety strap in addition to the draw sheet in the linen kit prior to surgery. The patient began to slip and fall from the table. The surgeon released the laparoscopic surgical tools in order to catch and prevent patient from falling to the floor. Operation was resumed it was determined the patient suffered a grade three laceration of the liver. Patient was admitted to the icu for three days eventually discharged home. It was suggested by the surgeon that the draw sheet was the cause of the patient slipping and nearly falling. The complaint cannot be confirmed and a root cause has not been determined. The sample was not returned for evaluation. Due to the new injury and increased length of hospitalization this medwatch is being filed.
Patient Sequence No: 1, Text Type: N, H10
[58325846]
A patient had a near fall from the operating table related to the draw sheet.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2016-00109 |
| MDR Report Key | 6055283 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-10-25 |
| Date of Report | 2016-10-25 |
| Date of Event | 2016-09-12 |
| Date Mfgr Received | 2016-09-30 |
| Device Manufacturer Date | 2016-05-01 |
| Date Added to Maude | 2016-10-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | MEGAN DEBUS |
| Manufacturer Street | ONE MEDLINE PLACE |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal | 60060 |
| Manufacturer Phone | 8476433962 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | DARW SHEET IN LINEN KIT |
| Product Code | KME |
| Date Received | 2016-10-25 |
| Catalog Number | DYKQSL3C |
| Lot Number | 2216050044 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES INC |
| Manufacturer Address | ONE MEDLINE PLACE MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2016-10-25 |