MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-22 for ECOLAB CLEANOP KIT SURGICAL POSITIONING STRAP CHSMF-02D manufactured by Ecolab.
[68407298]
Patient was undergoing a laparoscopic appendectomy. He was positioned in tredelenburg with a 45 degree tilt to the left side. A strap was placed around his thighs for positioning. During the procedure, the plastic loop on the strap broke and the patient slid toward the floor. He was caught and eased down by the surgeon and techs who were on the left side of the bed. At the time the strap broke the patient had 3 trocars inserted in his abdomen as well as an endotracheal tube that was dislodged. His head did not hit the floor, but did hit the iv pole stand behind the table. He was lifted back onto the table, the trocars were removed, he was re-prepped and draped and trocars inserted into the original tracts. There was no damage noted upon direct visualization. He was re-intubated easily without evidence of trauma. He sustained a small hematoma on his left forehead that disappeared within 2-3 days. X-rays demonstrated no injuries. He remained hospitalized for 8 days of iv antibiotics due to a diagnosis of peritonitis prior to surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5068092 |
| MDR Report Key | 6356235 |
| Date Received | 2017-02-22 |
| Date of Report | 2017-02-22 |
| Date of Event | 2017-02-14 |
| Date Added to Maude | 2017-02-24 |
| 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 | ECOLAB CLEANOP KIT SURGICAL POSITIONING STRAP |
| Generic Name | BEDDING DISPOSABLE, MEDICAL |
| Product Code | KME |
| Date Received | 2017-02-22 |
| Model Number | CHSMF-02D |
| Lot Number | J17025 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ECOLAB |
| Manufacturer Address | 1 ECOLAB PLACE ST. PAUL MN 55102 US 55102 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-02-22 |