MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-30 for THERMACARE NECK, SHOULDER & WRIST manufactured by Pfizer Consumer Health Care.
[189094234]
I used the wrap on my neck and somehow i ate some of it [accidental device ingestion] ,. Case narrative:this is a spontaneous report from a non-contactable consumer (patient). A (b)(6) year-old patient of an unspecified gender started to use thermacare heatwrap (thermacare neck, shoulder & wrist) (device lot number and expiration date not provided) from an unspecified date for an unspecified indication. Relevant medical history and the relevant concomitant medications were unknown at the time of this report. Patient reported on unknown date to have used the wrap on neck and somehow patient ate some of it. Patient was asking what to do. Action taken with the thermacare therapy in response to the event and the outcome of the event were unknown at the time of this report. No follow-up attempts are possible. No further information is expected. , comment: based on the available information, the report of "used the wrap on neck and somehow patient ate some of it" was considered serious as it may necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure or function. A causal relationship between the device and the reported event cannot be ruled out.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1066015-2020-00089 |
| MDR Report Key | 9898842 |
| Report Source | CONSUMER |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-18 |
| Date Added to Maude | 2020-03-30 |
| 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 NECK, SHOULDER & WRIST |
| Generic Name | DISPOSABLE PACK, HOT |
| Product Code | IMD |
| Date Received | 2020-03-30 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| 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 | 2020-03-30 |