MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1997-01-08 for TECNOL MEDICAL PRODUCTS, INC 18686-010 manufactured by .
| Report Number | 1625443-1997-00001 |
| MDR Report Key | 61940 |
| Report Source | 06 |
| Date Received | 1997-01-08 |
| Date of Report | 1997-01-08 |
| Date of Event | 1996-11-08 |
| Date Mfgr Received | 1996-12-11 |
| Date Added to Maude | 1997-01-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TECNOL MEDICAL PRODUCTS, INC |
| Generic Name | ADULT ARTERIAL HAND-AID WRIST SUPPORT |
| Product Code | BTX |
| Date Received | 1997-01-08 |
| Model Number | NA |
| Catalog Number | 18686-010 |
| Lot Number | UNK |
| Operator | UNKNOWN |
| Device Availability | * |
| Device Age | * |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 54083 |
| Baseline Brand Name | ADULT ARTERIAL HAND-AID WRIST SUPPORT |
| Baseline Generic Name | I.V. SUPPORT |
| Baseline Model No | NA |
| Baseline Catalog No | 18686-010 |
| Baseline ID | NA |
| Baseline Device Family | I.V. THERAPY PRODUCTS |
| Baseline Shelf Life Contained | A |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K820038 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-01-08 |