MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 1998-11-13 for BREMER ADJUSTABLE RING HT002 manufactured by Bremer Medical, Inc..
[15482688]
When applying the bremer adjustable ring, the skull pins would not tighten sufficiently and the lock nuts slackened when being fixed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1035798-1998-00003 |
| MDR Report Key | 197223 |
| Report Source | 05,07 |
| Date Received | 1998-11-13 |
| Date of Report | 1998-07-29 |
| Date of Event | 1998-01-01 |
| Date Mfgr Received | 1998-10-15 |
| Date Added to Maude | 1998-11-18 |
| 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 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BREMER ADJUSTABLE RING |
| Generic Name | ORTHOTIC DEVICE |
| Product Code | HAX |
| Date Received | 1998-11-13 |
| Returned To Mfg | 1998-10-15 |
| Model Number | NA |
| Catalog Number | HT002 |
| Lot Number | 27267 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 191613 |
| Manufacturer | BREMER MEDICAL, INC. |
| Manufacturer Address | 4801 DAWIN RD. JACKSONVILLE FL 322079512 US |
| Baseline Brand Name | BREMER ADJUSTABLE RING |
| Baseline Generic Name | SKULL TONGS |
| Baseline Model No | NA |
| Baseline Catalog No | HT002 |
| Baseline ID | NA |
| Baseline Device Family | BREMER HALO SYSTEM |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K915800 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1998-11-13 |