MAUDE Adverse Event Report: COVIDIEN XEROFORM 1X8 OVERWRAP 200 CNT; DRESSING, WOUND, DRUG

Model Number	8884431302
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Unspecified Infection (1930); Tissue Damage (2104)
Date of Event	12/22/2019
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 she placed a piece of xeroform gauze over a superficial wound on her toe and covered it with a band aid.The band aid was saturated and when she removed the band aid, there was a full thickness burn after wearing shoes for 4 hours.Additional information provided by the customer stated that the injury is at the 2nd digit of her left toe.She did not consult a clinician when she first had the injury.She used bacitracin ointment and was doing self wound care.On (b)(6) 2020, the customer consulted a podiatrist and was prescribed santyl ointment.She used it for two days and it did not improve the wound.On (b)(6) 2020 an x-ray was done to the affected area.On the (b)(6) an mri was done and the customer was diagnosed with osteomyelitis.(b)(6) 2020 the customer was prescribed cefepime 1 gram iv twice a day for 45 days and is on the third day of treatment at home.

• Brand Name: XEROFORM 1X8 OVERWRAP 200 CNT
• Common Device Name: DRESSING, WOUND, DRUG
• Manufacturer (Section D): COVIDIEN; 1430 marvin griffin road, po b; augusta GA 30906
• MDR Report Key: 9687313
• Report Number: 1018120-2020-00402
• Device Sequence Number: 3341181
• Product Code: FRO
• UDI-Device Identifier: 10884527014897
• UDI-Public: 10884527014897
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/10/2020

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 Model Number: 8884431302
• Device Catalogue Number: 8884431302
• Device Lot Number: 8010804
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2020
• Initial Report FDA Received Date: 02/10/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other