MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-16 for KENDALL 3615C manufactured by Cardinal Health 200, Llc.
[183519227]
Patient was to have spine surgery. Patient had latex/natural rubber precautions r/t spinal bifida. Prior to bringing patient into operating room, products that contained latex for patient care were replaced with latex-free options. Immediately after applying 4-inch positioning tape to patient's leg for traction, patient's vital signs desaturated. Anesthesia was called immediately to operating room and patient was stabilized. Surgical procedure was then cancelled. Later in day the surgeon and staff learned that the 4-inch positioning tape ref # 3615c used is composed of latex and natural rubber. However, tape is removed from outer packaging and placed on exchange cart - label nor roll states latex- only outer box from purchasing states latex. This is an item that is used regularly in the operating room esp orthopedics as a positioning aid.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9835163 |
| MDR Report Key | 9835163 |
| Date Received | 2020-03-16 |
| Date of Report | 2020-02-12 |
| Date of Event | 2020-02-06 |
| Report Date | 2020-02-12 |
| Date Reported to FDA | 2020-02-12 |
| Date Reported to Mfgr | 2020-03-16 |
| Date Added to Maude | 2020-03-16 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | KENDALL |
| Generic Name | TAPE AND BANDAGE, ADHESIVE |
| Product Code | KGX |
| Date Received | 2020-03-16 |
| Model Number | 3615C |
| Catalog Number | 3615C |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH 200, LLC |
| Manufacturer Address | 785 FORT MILL HWY. FORT MILL SC 29707 US 29707 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-16 |