MAUDE Adverse Event Report: COVIDIEN 7831 PKG STRPS IODOFORM1/4X5YD; GAUZE/SPONGE, INTERNAL

Model Number	7831
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/15/2021
Type of Reportable Event	Serious Injury
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 the patient had surgery to remove a cyst on her back in 2021 at the pa-c.At the appointment to have her stitches removed, it was determined that the wound was infected.The pa packed the wound with expired iodoform packing strips.The expiration date was 2016-04, ref (b)(4).The patient was started on cefalexin bid for 10 days.Attempts have been conducted to gather clarification of the reported event.To date, no clarification has been received to confirm if the iodoform packing strip contributed to the infection.If additional pertinent information becomes available, the report will be updated.

• Brand Name: 7831 PKG STRPS IODOFORM1/4X5YD
• Common Device Name: GAUZE/SPONGE, INTERNAL
• Manufacturer (Section D): COVIDIEN; 1430 marvin griffin road, po b; augusta GA 30906
• MDR Report Key: 12316147
• Report Number: 1018120-2021-00452
• Device Sequence Number: 11889179
• Product Code: EFQ
• UDI-Device Identifier: 10884521068704
• UDI-Public: 10884521068704
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/12/2021

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 Expiration Date: 04/30/2016
• Device Model Number: 7831
• Device Catalogue Number: 7831
• Device Lot Number: 140000794262X
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/29/2021
• Initial Report FDA Received Date: 08/12/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other