MAUDE Adverse Event Report: COVIDIEN 3X4 NONADHERENT PAD WITH PHMB; GAUZE/SPONGE, INTERNAL

Model Number	766299G
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
It was reported by a consumer that the dressing stuck to his wound.No follow up medical treatment was needed.

• Brand Name: 3X4 NONADHERENT PAD WITH PHMB
• Common Device Name: GAUZE/SPONGE, INTERNAL
• Manufacturer (Section D): COVIDIEN; 1430 marvin griffin road, po b; augusta GA 30906
• MDR Report Key: 10351191
• Report Number: 1018120-2020-00418
• Device Sequence Number: 14188547
• Product Code: EFQ
• UDI-Device Identifier: 10884521172036
• UDI-Public: 10884521172036
• 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): 07/31/2020

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: 766299G
• Device Catalogue Number: 766299G
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2020
• Initial Report FDA Received Date: 07/31/2020
• Patient Sequence Number: 1
• Patient Age: 85 YR