MAUDE Adverse Event Report: RAYNHAM SURG PATXRAY 1/4X1/4-200; SURGICAL PATTIES

Model Number	801399
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A nurse reported a surgical patty (id (b)(4)) was placed in a patient¿s throat and it began to disintegrate causing fibers to loosen and stay in the throat.The product and fibers were all removed from patient.It is unknown if there was a surgical delay.
Additional Manufacturer Narrative
The device involved in the reported incident is not available for evaluation.An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Additional Manufacturer Narrative
The surgical pattie was not returned for evaluation; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The root cause(s) of the reported issue could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: SURG PATXRAY 1/4X1/4-200
• Common Device Name: SURGICAL PATTIES
• Manufacturer (Section D): RAYNHAM; 325 paramount drive; 325 paramount drive; raynham MA
• Manufacturer (Section G): RAYNHAM; 325 paramount drive; raynham MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 14160283
• Report Number: 3014334038-2022-00076
• Device Sequence Number: 11499155
• Product Code: HBA
• UDI-Device Identifier: 10381780514954
• UDI-Public: 10381780514954
• Combination Product (Y/N): N
• PMA/510(K) Number: K880402
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2022

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
• Operator of Device: Health Professional
• Device Model Number: 801399
• Device Catalogue Number: 801399
• Device Lot Number: 5955307
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/06/2022
• Supplement Date Received by Manufacturer: 06/24/2022
• Initial Report FDA Received Date: 04/20/2022
• Supplement Report FDA Received Date: 07/13/2022
• Date Device Manufactured: 02/08/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown