MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-12-02 for * SG-100-566 manufactured by Mtd, Inc..
[102423]
Pt is an 82 yr old female with past med history of tia, chronic copd, chronic gastroesophageal reflux, osteoarthritis with osteoporosis, hypothyroidism with exophthalmia, and hypertension. Pt had been seen in the emergency dept as a result of a fall at home on 10/20/97. Hip fracture was ruled-out and pt discharged home. Pt returned to hosp on 11/1/97 with continued complaint of back pain. On 11/1/97, pt was taken to the radiology dept to undergo a nuclear medicine bone scan. A head/neck extension was attached to the end of the table to enable proper positioning of the pt on the table for the exam. At the conclusion of the exam, the radiation technologist turned away from the pt to check the images on a computer scan. Less than a min later, a crash was heard and the pt was found on the floor at the head of the table. The neck/extension was on the floor. The pt was examined in the emergency dept and taken back to her hosp unit. Ct of the head and neck were performed (11/3/97) which did not reveal any intracerebral bleed. Five rib fractures were found. The pt was treated with pain medication for the rib fractures. However, do to her already compromised respiratory condition, pneumonia set in. The pt was made dnr and subsequently expired on 11/10/97. A med examiner's autopsy is being undertaken, results are pending.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1012570 |
| MDR Report Key | 135741 |
| Date Received | 1997-12-02 |
| Date of Report | 1997-11-21 |
| Date of Event | 1997-11-03 |
| Date Added to Maude | 1997-12-05 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | HEAD/NECK EXTENSION FOR NUCLEAR MEDICINE TABLE |
| Product Code | IWY |
| Date Received | 1997-12-02 |
| Model Number | SG-100-566 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | 988 5864 REV C |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 132610 |
| Manufacturer | MTD, INC. |
| Manufacturer Address | 365 AMITY RD. ANDOVER NJ 07821 US |
| Baseline Brand Name | MTD HEDREST |
| Baseline Generic Name | SKULL POSITIONER |
| Baseline Model No | SG-100 |
| Baseline Catalog No | 9885864 REVC |
| Baseline ID | * |
| Baseline Device Family | HEADHOLDER |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 1997-12-02 |