MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; SURGICAL PACK

Catalog Number	DYNJ84642
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	10/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, after securing a drape with a metal clamp on the animal's skin for a procedure the animal "developed a burn after 5-7 days in the same area where the clamps were".The customer reported the animal required treatment with "enrofloxacin".The customer reported the animal is in the "final stages of wound healing".Sample requested for return evaluation.It has been determined that the reported event caused or contributed to serious injury, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
According to the customer, after securing a drape with a metal clamp on the animal's skin for a procedure the animal "developed a burn after 5-7 days in the same area where the clamps were".

• Common Device Name: SURGICAL PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 18060432
• Report Number: 1423395-2023-00067
• Device Sequence Number: 6628965
• Product Code: LRO
• UDI-Device Identifier: 10195327388089
• UDI-Public: 10195327388089
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/02/2023

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: Health Professional
• Device Catalogue Number: DYNJ84642
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2023
• Initial Report FDA Received Date: 11/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown