MAUDE Adverse Event Report: WAL-MART STORES, INC. EQUATE MAXI PADS; PAD, MENSTRUAL, UNSCENTED

Lot Number 22006K86

Device Problem Device Emits Odor (1425)

Patient Problems Abdominal Pain (1685); Hemorrhage/Bleeding (1888); Rash (2033); Sleep Dysfunction (2517); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 02/13/2022

Event Type  Injury  

Event Description

Reporter calling about an adverse event after use of (b)(6) brand maxi pads purchased at (b)(6).She states she noticed a harsh chemical smell upon opening the box.During the course of product use, she developed a rash that progressed to bleeding, abdominal pain, and bladder spasms.These symptoms interrupted her typical sleep pattern and persisted for approximately seven days even after she ended use of the products.She states she used twelve pads in total.She contacted the telephone number listed on the box to report this problem and also returned two devices to them for evaluation, per instruction.After expressing her concerns to them regarding this product, she felt they were somewhat dismissive and so is reporting to the fda to ensure this matter will be looked into.She states she does not want anyone else to experience the same problems she did.She states the item number from her purchase receipt is (b)(4).

• Brand Name: EQUATE MAXI PADS
• Type of Device: PAD, MENSTRUAL, UNSCENTED
• Manufacturer (Section D): WAL-MART STORES, INC.; 702 sw 8th st.; bentonville AR 72716
• MDR Report Key: 13757604
• MDR Text Key: 287247070
• Report Number: MW5108118
• Device Sequence Number: 5
• Product Code: HHD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/07/2022
• 12 Devices were Involved in the Event: 1 2 3 4 5 6 7 8 9 10 11 12

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Lot Number: 22006K86
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/11/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Sex: Female