MAUDE Adverse Event Report: MECHANICSVILLE, O&M HALYARD, INC. AERO CHROME GOWN; SURGICAL GOWNS

Model Number UNKNOWN

Device Problem No Apparent Adverse Event (3189)

Patient Problem Insufficient Information (4580)

Event Date 01/18/2022

Event Type  malfunction  

Manufacturer Narrative

The actual complaint product was not returned for evaluation.A review of the device history record is in-progress.Upon completion of the investigation; a follow-up report will be filed.It was reported that there was white fuzz coming off of the surgical gown cuff on the sleeves.(b)(6) hospital noticed fuzz on the field - on and off for the last couple of months, but couldn't find the source of the mysterious fuzz.This could be an issue if the fuzz is shedding off after someone has slid their arms through the sleeves or from up around the collar of the gown.We have noticed an increase of surgical site infections.Additional information has been requested for the product code and lot number but has not been received.All information reasonably known as of 15feb2022 has been included in this medical device report.Should additional information be obtained, a follow-up medical device report will be provided.O&m halyard, inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the o&m halyard, inc.Complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that o&m halyard, inc.Product is defective or caused serious injury.

Event Description

It was reported that there was white fuzz coming off of the surgical gown cuff on the sleeves.(b)(6) hospital noticed fuzz on the field - on and off for the last couple of months, but couldn't find the source of the mysterious fuzz.This could be an issue if the fuzz is shedding off after someone has slid their arms through the sleeves or from up around the collar of the gown.We have noticed an increase of surgical site infections.Additional information has been requested for the product code and lot number but has not been received.

Manufacturer Narrative

The actual complaint product was not returned for evaluation.It was initially reported that there was white fuzz coming off of the surgical gown cuff on the sleeves.(b)(6) hospital noticed fuzz on the field - on and off for the last couple of months, but couldn't find the source.The hospital has noticed an increase of surgical site infections.The investigation was performed per the information provided in the complaint record.A sample or picture was not made available to confirm the failure.A valid lot number has not been provided.The customer did not provide a specific gown family or product code; however, the possible product codes have been identified.Since the defect is related to the cuff, the investigation was focused on all surgical gowns which utilize the same cuff provided by dingshun medical.There have been no reports of linting from the cuff discovered during incoming inspection or in-process inspections.There have been no other complaints reported for this issue in any gown family.Based on the information reviewed, a specific root cause could not be identified.All information reasonably known as of 13apr2022 has been included in this medical device report.The information provided by o&m halyard, inc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to o&m halyard, inc.O&m halyard, inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the o&m halyard, inc.Complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that o&m halyard, inc.Product is defective or caused serious injury.H3 other text : device not returned.

• Brand Name: AERO CHROME GOWN
• Type of Device: SURGICAL GOWNS
• Manufacturer (Section D): MECHANICSVILLE, O&M HALYARD, INC.; 9120 lockwood blvd.; mechanicsville VA 23116
• Manufacturer (Section G): O&M HALYARD HONDURAS S.A. DE C.V.; parque indust. zoli villanueva; carretera de tegucigalpa; carret de teg, villanueva, cortés 21000 ; HO 21000
• Manufacturer Contact: nichole early ; 1 edison drive; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 13542090
• MDR Text Key: 296329292
• Report Number: 9680646-2022-00001
• Device Sequence Number: 1
• Product Code: FYA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200522
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/09/2022
• 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: Unknown
• Patient Sequence Number: 1