MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2009-12-09 for FAULTLESS, GOODHEALTH WATER BOTTLE 02816 02816 - REGULAR manufactured by Apothecary Products, Inc..
[19934622]
Customer feedback was received in 2009 from grandmother of child with type 1 diabetes. Complaint states that the water bottle leaked producing a 2" x 3" burn on child's leg. Grandmother explains that patient "has always been very sensitive to hot water i. E. Her showers are always kind of cool". We have attempted to obtain the water bottle for evaluation as well as the contact information of patient's doctor but have been informed that legal advice from attorney has resulted in denials of our requests. Water bottle packaging label has been reviewed and includes the following: use only plain tap water under 120 degrees f/49 degrees c in this bottle. Using anything other than plain tap water could damage bottle and cause to break. Note: for user's safety, water used should never be warmer than is comfortable to touch. Even hot tap water can cause burns. Do not expose bottle to direct sunlight or other heat. Caution: for application to sensitive skin areas, wrap soft cloth or towel around bottle. Test for leakage by turning bottle upside down and pressing firmly. A follow-up report will be submitted if water bottle becomes available for evaluation or additional information is obtained.
Patient Sequence No: 1, Text Type: N, H10
[19955365]
Patient is type 1 diabetes. Grandmother filled water bottle with warm tap water to warm the sheets as patient was not feeling well and was going to bed. The water bottle allegedly "leaked" producing a reported 2" x 3" second degree burn on the patient's leg (just above the ankle). Skin appears (by photo) to have blistered and the skin is reported to be "lifting off the area" of the injury. Patient has been receiving out-patient medical treatment at wound clinic.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183416-2009-00001 |
| MDR Report Key | 1561057 |
| Report Source | 04 |
| Date Received | 2009-12-09 |
| Date of Report | 2009-11-12 |
| Date of Event | 2009-11-02 |
| Date Mfgr Received | 2009-11-12 |
| Device Manufacturer Date | 2009-05-01 |
| Date Added to Maude | 2009-12-22 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | JAMES JENKINS |
| Manufacturer Street | 11750 12TH AVE. SOUTH |
| Manufacturer City | BURNSVILLE MN 55337 |
| Manufacturer Country | US |
| Manufacturer Postal | 55337 |
| Manufacturer Phone | 9528088364 |
| Single Use | 3 |
| Remedial Action | RB |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FAULTLESS, GOODHEALTH WATER BOTTLE |
| Generic Name | BOTTLE, HOT/COLD, WATER |
| Product Code | FPF |
| Date Received | 2009-12-09 |
| Model Number | 02816 |
| Catalog Number | 02816 - REGULAR |
| Lot Number | 122DB02 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | APOTHECARY PRODUCTS, INC. |
| Manufacturer Address | 11750 12TH AVE. SOUTH BURNSVILLE MN 55337 US 55337 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-12-09 |