MAUDE Adverse Event Report: MEDTRONIC XOMED INC. MEROCEL® 2000 NASAL PACKING; GAUZE/SPONGE,NONRESORBABLE FOR EXTERNAL USE

Model Number	470404
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of this report: 01/18/2017.Describe event problem: additional information received: the doctor confirmed that ¿she had the packing anchored.She taped it onto the patient¿s cheek.¿ date manufacturer received: 02/06/2017 conclusion: operational context caused or contributed to event (b)(4); a good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received: the doctor confirmed that ¿she had the packing anchored.She taped it onto the patient¿s cheek.¿.
Additional Manufacturer Narrative
Product evaluation: analysis results are not available; the device was not returned for evaluation.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient swallowed the packing after leaving the facility where it was placed.Information available at this time indicates that the device was cut in half to use and was not anchored once placed.There was no patient impact.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: MEROCEL® 2000 NASAL PACKING
• Common Device Name: GAUZE/SPONGE,NONRESORBABLE FOR EXTERNAL USE
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr north; jacksonville FL 32216
• MDR Report Key: 6323339
• Report Number: 1045254-2017-00055
• Device Sequence Number: 11142572
• Product Code: NAB
• UDI-Device Identifier: 00681490115056
• UDI-Public: 00681490115056
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/18/2017

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: 470404
• Device Catalogue Number: 470404
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/18/2017
• Supplement Date Received by Manufacturer: Not provided; 02/06/2017
• Initial Report FDA Received Date: 02/10/2017
• Supplement Report FDA Received Date: 02/13/2017; 09/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR