MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2003-04-24 for DRAPE TAPES 3524CE manufactured by Cardinal Health.
[304724]
Pt's skin was peeled off when the drape tape was removed. The same surface area as the tape size, (10x15cm) was peeled. It took one and a half hours for the operation. They didn't use any chemicals except povidone solution and physiological saline. There were damaged areas to the pt's stratum corneum or stratum lucidum, not the whole epidermis. The pt was given the ointment of oxyteracycline hcl/hydrocortisone. The next day, the reddish peeled area appeared normal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423507-2003-00057 |
| MDR Report Key | 455699 |
| Report Source | 01,07 |
| Date Received | 2003-04-24 |
| Date of Report | 2003-04-24 |
| Date of Event | 2003-03-27 |
| Date Mfgr Received | 2003-03-27 |
| Date Added to Maude | 2003-04-28 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | PATRICIA SHARPE-GREGG |
| Manufacturer Street | 1430 WAUKEGAN RD |
| Manufacturer City | MCGAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8475784148 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRAPE TAPES |
| Generic Name | DRAPE TAPES |
| Product Code | KGT |
| Date Received | 2003-04-24 |
| Model Number | 3524CE |
| Catalog Number | 3524CE |
| Lot Number | 02HBJ028 |
| 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 | 444681 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | 1430 WAUKEGAN RD. MCGAW PARK IL 60085 US |
| Baseline Brand Name | DRAPE TAPES |
| Baseline Generic Name | DRAPE TAPES |
| Baseline Model No | 3524CE |
| Baseline Catalog No | 3524CE |
| Baseline Device Family | SURGICAL ACCESSORY |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-04-24 |