MAUDE Adverse Event Report: COVIDIEN DRSG,NON-ADH,DRY, 8X3'',PEEL PCK; DRESSING,WOUND,OCCLUSIVE

Model Number	1238
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation as it has been discarded; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.  as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.  if additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
The customer reported that the patient had craniotomy surgery and a retained sponge was noted in the mri post surgery.Disclosure to the patient/ parents was done.Per neurosurgery progress notes, in reviewing the patient¿s postop mri, there was a notable t2 hyperintensity in the interhemispheric fissure posteriorly which was not noted on the patient¿s preoperative mri.There was a concern for retained foreign object, specifically telfa used for protection of the cerebral cortex during the dissection of the interhemispheric fissure.Although the surgical counts were correct at the end of the operative procedure, the telfa was cut into strips and then counted.The telfa used does not have strings attached to facilitate counting.In reviewing with other operative personnel present during the surgery, it appears that one piece of counted telfa may have been cut again and the count not updated.This may account for the discrepancy between the correct surgical count and the apparent retained telfa visualized on mri.The patient was scheduled to go back to the operating room for the removal of the retained telfa (exploration of left frontal craniotomy for removal of retained foreign body).The foreign object was successfully removed.The current status of the patient is stable.

• Brand Name: DRSG,NON-ADH,DRY, 8X3'',PEEL PCK
• Common Device Name: DRESSING,WOUND,OCCLUSIVE
• Manufacturer (Section D): COVIDIEN; 1430 marvin griffin road, po b; augusta GA 30906
• MDR Report Key: 10086818
• Report Number: 1018120-2020-00412
• Device Sequence Number: 14184029
• Product Code: NAD
• UDI-Device Identifier: 10884521065307
• UDI-Public: 10884521065307
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/26/2020

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: 1238
• Device Catalogue Number: 1238
• Device Lot Number: 19M026062
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2020
• Initial Report FDA Received Date: 05/26/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 10 YR