MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2004-08-31 for HEMOVAC KIT * 00-2550-002-10 manufactured by Zimmer Orthopaedic Surgical Products.
[19144945]
In 2004 dr attempted to remove a 1/8" hemovac drain, model number 00-2550-002-10 from a pt postoperatively on the floor. The attempt failed when the drain allegedly broke. The physician cut off and discarded the torn end of the drain prior to bringing the pt back to the or for surgical removal of the remaining portion of the drain. The remainder of the drain was successfully removed and was sent to pathology.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526350-2004-00016 |
| MDR Report Key | 541340 |
| Report Source | 05,06 |
| Date Received | 2004-08-31 |
| Date of Report | 2004-07-19 |
| Date of Event | 2004-05-27 |
| Date Facility Aware | 2004-07-28 |
| Report Date | 2004-07-19 |
| Date Reported to Mfgr | 2004-07-28 |
| Date Mfgr Received | 2004-07-28 |
| Date Added to Maude | 2004-09-01 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JOYCE ELKINS |
| Manufacturer Street | 200 W. OHIO AVE. |
| Manufacturer City | DOVER OH 44622 |
| Manufacturer Country | US |
| Manufacturer Postal | 44622 |
| Manufacturer Phone | 3303649483 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEMOVAC KIT |
| Generic Name | WOUND DRAINAGE DEVICE |
| Product Code | ILZ |
| Date Received | 2004-08-31 |
| Model Number | * |
| Catalog Number | 00-2550-002-10 |
| Lot Number | NI |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NO INFO |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | I |
| Device Sequence No | 1 |
| Device Event Key | 530676 |
| Manufacturer | ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS |
| Manufacturer Address | 200 WEST OHIO AVE. DOVER OH 44622 US |
| Baseline Brand Name | TRAPEZE, HEAVY DUTY |
| Baseline Catalog No | 0640-067 |
| Baseline ID | TRAPEZE |
| Baseline Device Family | NA |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2004-08-31 |