THERMACARE ADVANCED MENSTRUAL PAIN T

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-28 for THERMACARE ADVANCED MENSTRUAL PAIN T manufactured by .

Event Text Entries

[129027796] (b)(4), (b)(6) 2018 - thermacare advanced menstrual pain therapy (3 count) heatwraps, up to 8 hours pain relief, temporary relief of menstrual cramp pain, back aches, (b)(6) 2018. I sustained burns and irritating rash like symptoms as a result of using the product mentioned above. Date the person first started taking or using the product: (b)(6) 2018; date the person stopped taking or using the product: (b)(6) 2018. Frequency: as needed. How was it taken or used? Topical. Reason for use: pelvic pain.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	MW5081710
MDR Report Key	8115611
Date Received	2018-11-28
Date of Report	2018-11-27
Date of Event	2018-11-01
Date Added to Maude	2018-11-29
Event Key	0
Report Source Code	Voluntary report
Manufacturer Link	N
Number of Patients in Event	0
Adverse Event Flag	3
Product Problem Flag	3
Reprocessed and Reused Flag	3
Reporter Occupation	PATIENT
Health Professional	3
Initial Report to FDA	3
Report to FDA	3
Event Location	3
Single Use	3
Previous Use Code	3
Event Type	3
Type of Report	0

Device Sequence Number: 0

Brand Name	THERMACARE ADVANCED MENSTRUAL PAIN T
Generic Name	PACK, HOT OR COLD, REUSABLE
Product Code	IME
Date Received	2018-11-28
Lot Number	B010FB4D2O
Device Availability	Y
Device Eval'ed by Mfgr	I
Device Sequence No	0
Device Event Key	0

Device Sequence Number: 1

Brand Name	THERMACARE ADVANCED MENSTRUAL PAIN T
Generic Name	PACK, HOT OR COLD, REUSABLE
Product Code	IME
Date Received	2018-11-28
Lot Number	B010FB4D2O
Device Availability	Y
Device Eval'ed by Mfgr	I
Device Sequence No	1
Device Event Key	0
Manufacturer	PFIZER, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Deathisabilit	2018-11-28