MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. WALGREENS; GLOVE,EXAM,VINYL,PF,200CT,OSFM

Model Number 218257

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 01/20/2021

Event Type  Injury  

Manufacturer Narrative

It was reported that the first time that the employee used the gloves she began to experience swelling on both of her hands and arms within twenty minutes.The employee reportedly went to her own primary care physician and was off of work for an unreported period of time, however no additional information was available at the time of the initial report.Follow up information was obtained on (b)(6) 2021 and it was reported that when the employee went to see her family doctor she was treated with a depo-medrol injection in the office as well as zyrtec, keflex and prednisone to take as directed for an unknown allergic reaction.No additional information is available.The sample was returned to the manufacturer for evaluation and the sample review showed the lot met all acceptable specifications.Due to the reported incident and 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

It was reported that the first time that the employee used the gloves she began to experience swelling on both of her hands and arms within twenty minutes.

• Brand Name: WALGREENS
• Type of Device: GLOVE,EXAM,VINYL,PF,200CT,OSFM
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093
• MDR Report Key: 11375029
• MDR Text Key: 233438248
• Report Number: 1417592-2021-00025
• Device Sequence Number: 1
• Product Code: LYZ
• UDI-Device Identifier: 00311917150970
• UDI-Public: 00311917150970
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 02/24/2021

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
• Device Operator: Lay User/Patient
• Device Model Number: 218257
• Device Catalogue Number: WRX218257V1
• Device Lot Number: MF013149373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/18/2021
• Initial Date FDA Received: 02/24/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Weight: 86