MAUDE Adverse Event Report: COVIDIEN DERMACEA X-RAY SPG 4X4 16 PLY; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Model Number	441601
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation; 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 gauze was coming apart.There was no patient injury.

• Brand Name: DERMACEA X-RAY SPG 4X4 16 PLY
• Common Device Name: GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11240045
• Report Number: 1282497-2021-09869
• Device Sequence Number: 19737100
• Product Code: GDY
• UDI-Device Identifier: 10884527021239
• UDI-Public: 10884527021239
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/27/2021

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: No Information
• Device Model Number: 441601
• Device Catalogue Number: 441601
• Device Lot Number: 190428
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/26/2021
• Initial Report FDA Received Date: 01/27/2021
• Patient Sequence Number: 1