MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2004-10-21 for DRAPE TOWEL, TIBURON 7554 manufactured by Cardinal Health.
[312471]
Used square off towels with adhesive. When removed pt skin was torn. Per o. R. Tech, upon removing drape after a lap hysterectomy case she noticed lacerations on each side of pt's thighs. Tech summoned surgeon and they performed a quick analysis of situation. The drape was inspected and skin found adhered to drape. They also reviewed instructions for the 3m duraprep solution used on pt's skin as well. Staff has been instructed to follow recommended use of prep solution and to carefully remove drape after each procedure. Surgeon administered approx two stitches to each laceration. Per o. R. Tech surgeon stated pt is doing fine post op and no other medical interventions at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423507-2004-00101 |
| MDR Report Key | 550341 |
| Report Source | 05,07 |
| Date Received | 2004-10-21 |
| Date of Report | 2004-10-21 |
| Date of Event | 2004-10-07 |
| Date Mfgr Received | 2004-10-07 |
| Device Manufacturer Date | 2003-04-01 |
| Date Added to Maude | 2004-10-25 |
| 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 | 0 |
| Manufacturer Contact | MICHELE DONATICH |
| Manufacturer Street | 1430 WAUKEGAN RD, BLDG KB |
| Manufacturer City | MCGAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8475786412 |
| Manufacturer G1 | SURGICAL GROUP - EL PASO |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRAPE TOWEL, TIBURON |
| Generic Name | DRAPE TOWEL, TIBURON |
| Product Code | KKK |
| Date Received | 2004-10-21 |
| Model Number | 7554 |
| Catalog Number | 7554 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 539869 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | * MCGAW PARK IL * US |
| Baseline Brand Name | DRAPE TOWEL, TIBURON |
| Baseline Generic Name | DRAPE TOWEL, TIBURON |
| Baseline Model No | 7554 |
| Baseline Catalog No | 7554 |
| Baseline Device Family | DRAPE |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K023419 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-10-21 |