MAUDE Adverse Event Report: COVIDIEN STD POROUS CLOTH TAPE 4IN 10YD, NS; TAPE AND BANDAGE, ADHESIVE

Model Number	3615C
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Reaction (2414)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.
Event or Problem Description
The customer reported that the patient was to have spine surgery.The patient had latex/natural rubber precautions related to spinal bifida.Prior to bringing the patient into the operating room, products that contained latex for patient care were replaced with latex free options.Immediately after applying four inch positioning tape to the patient's leg for traction, the patient's vital signs desaturated.Anesthesia was called immediately to the operating room and the patient was stabilized.The surgical procedure was cancelled.Later in the day the surgeon and staff learned that the four inch positioning tape used is composed of latex and natural rubber.However, the tape is removed from the outer packaging and placed on an exchange cart and the label nor the roll states latex, only the outer box from purchasing states latex.

• Brand Name: STD POROUS CLOTH TAPE 4IN 10YD, NS
• Common Device Name: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA
• MDR Report Key: 9948721
• Report Number: 1282497-2020-09001
• Device Sequence Number: 3296598
• Product Code: KGX
• UDI-Device Identifier: 10884521138858
• UDI-Public: 10884521138858
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Model Number: 3615C
• Device Catalogue Number: 3615C
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/24/2020
• Initial Report FDA Received Date: 04/10/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 13 YR