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

Model Number	441002
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Event or Problem Description
The customer reported that there was linting on the lap sponges.There was no patient harm.

• Brand Name: DERMACEA X-RAY 4X4 16 PLY STRL
• Common Device Name: GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 12438700
• Report Number: 1282497-2021-10596
• Device Sequence Number: 3651709
• Product Code: GDY
• UDI-Device Identifier: 10884527020911
• UDI-Public: 10884527020911
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/08/2021

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: 441002
• Device Catalogue Number: 441002
• Device Lot Number: 200505-121-SH
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/02/2021
• Initial Report FDA Received Date: 09/08/2021
• Patient Sequence Number: 1