MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-03-16 for THERMACARE MENSTRUAL manufactured by Pfizer Consumer Health Care.
[186140830]
Severe redness, blistering, detachment of skin and open wounds on the lower abdomen [burns second degree]. Case narrative: this is a spontaneous report from a contactable pharmacist via medical information team. A (b)(6) female patient started to receive thermacare heatwrap (thermacare menstrual), lot number and expiration date not provided, on an unknown date for unspecified indication. Relevant medical history and concomitant medications were not reported. On an unknown date the patient experienced severe side effects like severe redness, blistering, detachment of skin and open wounds on the lower abdomen. The action taken with thermacare heatwrap and outcome of the events were unknown. Additional information has been requested and will be provided as it becomes available. Comment: based on the information provided, the event burns second degree (described as redness, blistering, detachment of skin and open wounds on the lower abdomen) is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure. A causal relationship between the device and the event cannot be ruled out.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1066015-2020-00075 |
| MDR Report Key | 9836713 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-03-16 |
| Date of Report | 2020-03-05 |
| Date of Event | 2020-03-04 |
| Date Added to Maude | 2020-03-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS STELLA PIETRAFESA |
| Manufacturer Street | 235 E42ND STREET |
| Manufacturer City | NEW YORK NY 10017 |
| Manufacturer Country | US |
| Manufacturer Postal | 10017 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THERMACARE MENSTRUAL |
| Generic Name | DISPOSABLE PACK, HOT |
| Product Code | IMD |
| Date Received | 2020-03-16 |
| Lot Number | CG5595 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PFIZER CONSUMER HEALTH CARE |
| Manufacturer Address | 1231 WYANDOTTE DRIVE ALBANY GA 31705 US 31705 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-16 |