MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2000-08-29 for WALGREEN 02144 manufactured by Abbott Laboratories.
[182282]
Report of hot water bottle leak resulting in burn received. Info received via letter from customer which stated: consumer "purchased a walgreens water bottle for warm/cold applications. He advised that he poured hot water in the bag and sealed it. The bag was then wrapped in a towel and then applied to his left shoulder. Hot water then proceeded to leak through a seam in the bag resulting in the consumer sustaining a burn on his back. He also advised that as a result of the hot water suddenly touching his skin, he jumped and hit his head on the refrigerator. " no further info has become available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1520456-2000-00005 |
| MDR Report Key | 293531 |
| Report Source | 04 |
| Date Received | 2000-08-29 |
| Date of Report | 2000-07-31 |
| Date of Event | 2000-07-22 |
| Date Mfgr Received | 2000-07-31 |
| Date Added to Maude | 2000-09-01 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | FRANK POKROP, ASSOCIATE DIRECTR |
| Manufacturer Street | 200 ABBOTT PARK RD. DEPT 389,BLDG. J-45 |
| Manufacturer City | ABBOTT PARK IL 600646132 |
| Manufacturer Country | US |
| Manufacturer Postal | 600646132 |
| Manufacturer Phone | 8479378473 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WALGREEN |
| Generic Name | HOT WATER BOTTLE |
| Product Code | FPF |
| Date Received | 2000-08-29 |
| Model Number | NA |
| Catalog Number | 02144 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 284130 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 268 EAST FOURTH ST. ASHLAND OH 44805 US |
| Baseline Brand Name | WALGREEN |
| Baseline Generic Name | WATER BOTTLE WITH STOPPER |
| Baseline Model No | NA |
| Baseline Catalog No | 02144 |
| Baseline ID | NA |
| Baseline Device Family | NA |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | * |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-08-29 |