MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; TOWELS AND DRAPES FROM BREAST ABDOMINOPLASTY PACK

Catalog Number DYNJ0428947G

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Rash (2033)

Event Date 05/01/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that a patient required treatment with steroids after developing rashes from the drapes and towels (from the custom surgical tray).The rashes were reportedly noticed on the patient's face, axillae, trunk, and arms.It was denied that the patient developed rashes on the surgical site.Per report, the rashes were not noticed immediately after surgery and post-surgery, patient called and notified the breast clinic of the rashes.Per the initial reporter, "it is difficult for me to say if towels or drapes were the suspected culprit." due to the reported event and need for medical intervention, this medwatch is being filed.A sample is not available to be returned for evaluation.A definitive root cause for the reported issue could not be determined.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.

Event Description

It was reported that patient developed rashes from the towels and drapes and patient required steroids to treat these rashes.

• Type of Device: TOWELS AND DRAPES FROM BREAST ABDOMINOPLASTY PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: bermon punzalan ; three lakes drive; northfield, IL 60093
• MDR Report Key: 8752949
• MDR Text Key: 149947909
• Report Number: 1423395-2019-00025
• Device Sequence Number: 1
• Product Code: FTN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DYNJ0428947G
• Device Lot Number: 19BKA978
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention