MAUDE Adverse Event Report: TIDI PRODUCTS LLC TIDISHIELD CLEAR PROBE COVER 4" W X 32" L; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number	MICK-P432
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: the complaint product is expected to be returned, but not yet received by the manufacturer.Therefore, this report is based solely on customer provided information.Historical complaint data review identified no other similar complaints documented for this sku in the last 5 years.Manufacturing records did not reveal any nonconformances or other issues noted that could have contributed to the reported issue.Samples have been received by the distributor and are being prepared for return to the manufacturer for evaluation.At this time, there is not enough information to confirm the reported failure or to determine root cause.Manufacturer reference file: (b)(4).
Event or Problem Description
Per the product complaint report: "when used in the operating room we had 3 probe covers that were punctured.".

• Brand Name: TIDISHIELD CLEAR PROBE COVER 4" W X 32" L
• Common Device Name: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section D): TIDI PRODUCTS LLC; 570 enterprise drive; neenah WI 54956
• Manufacturer Contact: chris rahn ; 570 enterprise drive; neenah, WI 54956 ; 9207514300
• MDR Report Key: 17509493
• Report Number: 2182318-2023-00069
• Device Sequence Number: 6217495
• Product Code: IYO
• UDI-Device Identifier: 00618125143153
• UDI-Public: 00618125143153
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K090773
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: MICK-P432
• Device Catalogue Number: MICK-P432
• Device Lot Number: 030471
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2023
• Initial Report FDA Received Date: 08/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/23/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown