MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 1999-07-30 for WALGREEN 02144 manufactured by Abbott Laboratories.
[195031]
Follow-up #1. Date of event: 09/28/1999. Additional information was received regarding this event. Records state "this 64 year old lady is seen ungently because of a severe burn over her low back and both buttocks. Apparently she tried to use a new hot water bottle which broke as soon as she put it against her skin and she sustained quite a bad burn. She apparently saw dr. Over the weekend who told her to use some otc cream and told her to remain out ot work for a few days. She continues to have a good deal of difficulty with sitting and walking and really does not feel she can return to work. Dr has also dressed her buttocks area with bacitracin and dsd. Dr think she should remain out of work for at least the next 5-7 days and dr has told her that and have written it for her. " work release states "this lady has a severe burn (second degree) over her low back and both buttocks. Due to the pain and weeping skin, she cannot be at work for 5-7 more days. " records also state that the pt "reports onset of lower back pain appproximately 3 weeks ago when she twisted quickly. Reports she had a hot water bottle on upper back and bottle broke. States she jumped and she fell off bed onto floor. " pt was seen the next day and diagnosed with second degree burns. " dr's examination reported pt complaint of intermittant sharp pain of the left lower back, and findings on exam of tenderness/spasm left lumbar paraspinals. Pt received physical therapy and returned to work on 10/14/97. No further information was available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1520456-1999-00004 |
| MDR Report Key | 234503 |
| Report Source | 04 |
| Date Received | 1999-07-30 |
| Date of Report | 1999-07-01 |
| Date of Event | 1997-07-27 |
| Date Mfgr Received | 1999-07-01 |
| Date Added to Maude | 1999-08-06 |
| 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 | NANCY CONWAY, DIRECTOR, REGULAT |
| Manufacturer Street | 200 ABBOTT PARK RD. |
| Manufacturer City | ABBOTT PARK IL 600646157 |
| Manufacturer Country | US |
| Manufacturer Postal | 600646157 |
| Manufacturer Phone | 8479350595 |
| 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 | 1999-07-30 |
| 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 | 227280 |
| 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 | 1999-07-30 |