MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2001-09-24 for BREMER HALO SYSTEM HT026 manufactured by Depuy Acromed, Inc..
[232965]
It was reported that a pt wearing a depuy acromed halo had expired. The pt suffered a broken neck due to an accident. The pt was treated with a halo. It was reported that the pt was transferred 3 or 4 times between hosps, ending up in a rehabilitation center. During the pt's care there, the pt was moved and the halo got caught on the bedrail. The pt reported feeling a sharp pain. Within a week, the pt became a quadriplegic and expired in 2001. Based on the reported info, this event is not device related. It is related to the pt's care. The pt's family has retained the halo and it is not being returned for eval. No further action can be taken at this time.
Patient Sequence No: 1, Text Type: D, B5
[242883]
It was reported to depuy acromed thaa a pt expired while wearing a depuy acromed device. According to the complainant, the pt broke his neck and was placed in a bremer halo. He was transferred 3 or 4 times between hospitals due to insurance issues. It was reported that during his care in a rehabilitation center, the pt was being moved and the halo got caught on the bedrail. The pt complained of pain and within a short period of time became quadriplegic and expired on 8/19/2001. The pt's family will not release the halo for eval. The lot number was not provided. No further investigation could be performed. Based on the info made available to depuy acromed, the death of the pt is most likely not device related, but due to the improper care the pt received at the hosp. No further action can be taken.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526439-2001-00043 |
| MDR Report Key | 353124 |
| Report Source | 07 |
| Date Received | 2001-09-24 |
| Date of Report | 2001-09-24 |
| Date Mfgr Received | 2001-08-24 |
| Date Added to Maude | 2001-09-27 |
| 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 Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088808100 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BREMER HALO SYSTEM |
| Generic Name | LARGE HALO |
| Product Code | KQZ |
| Date Received | 2001-09-24 |
| Model Number | NA |
| Catalog Number | HT026 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 342364 |
| Manufacturer | DEPUY ACROMED, INC. |
| Manufacturer Address | 325 PARAMOUNT DR. RAYNHAM MA 02767 US |
| Baseline Brand Name | BREMER HALO SYSTEM |
| Baseline Generic Name | HALO CROWN |
| Baseline Model No | NA |
| Baseline Catalog No | HT026 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-09-24 |