MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; HEAD AND NECK PACK

Catalog Number DYNJ38880D

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/27/2023

Event Type  Injury  

Manufacturer Narrative

According to the customer contact, on (b)(6) 2023 the gauze was used on an incision in the neck and it was reported that the gauze was "shredding" in the incision.The customer reported the surgeon removed the gauze from the patient and it was removed from the field.The customer reported a five minute delay in the procedure due to the incident.No additional medical intervention or injury was reported.A sample has been requested to be returned for evaluation.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

Sponge shredding in incision.

• Type of Device: HEAD AND NECK PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 16996265
• MDR Text Key: 315877668
• Report Number: 1423395-2023-00022
• Device Sequence Number: 1
• Product Code: OGR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: DYNJ38880D
• Device Lot Number: 23AMA820
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other