MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1998-11-04 for U.S. PATTERN TUBE OCCLUDING CLAMP * V97-585 manufactured by Miltex Instrument Co. Inc..
[19171459]
"teck" while clamping large lumen tubing with u. S. Pattern tube occluding clamp, perforates or punctures tube. With small lumen tubing, reclamping at the same position may cause perforation. Condition is observation by hosp.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2431021-1998-00007 |
| MDR Report Key | 195650 |
| Report Source | 05 |
| Date Received | 1998-11-04 |
| Date of Report | 1998-10-29 |
| Date of Event | 1998-10-01 |
| Date Mfgr Received | 1998-10-29 |
| Date Added to Maude | 1998-11-09 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | U.S. PATTERN TUBE OCCLUDING CLAMP |
| Generic Name | TUBE OCCLUDING CLAMP |
| Product Code | FIG |
| Date Received | 1998-11-04 |
| Model Number | * |
| Catalog Number | V97-585 |
| Lot Number | UNK |
| ID Number | * |
| 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 | 190080 |
| Manufacturer | MILTEX INSTRUMENT CO. INC. |
| Manufacturer Address | 6 OHIO DR. - CB5006 LAKE SUCCESS NY 110420006 US |
| Baseline Brand Name | U.S. PATTERN |
| Baseline Generic Name | TUBE OCCLUDING CLAMP |
| Baseline Model No | V97-585 |
| Baseline Catalog No | V97-585 |
| Baseline ID | VANTAGE |
| Baseline Device Family | TUBING FORCEPS |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-11-04 |