MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2013-03-06 for DRAPE,TAPE,ADHESVIE,4INX18IN A3524 manufactured by Cardinal Health.
[3175356]
It was reported that there was peeling of skin (10cmx 10cm) above the knee when the drape tape was removed after surgery on a (b)(6) male with a hip fracture. The prep was done with chlorexidine 2% and alcohol 70%. A dressing with bactigras and compresses were applied. The patient was doing well overall.
Patient Sequence No: 1, Text Type: D, B5
[10553860]
No lot number was provided; without the lot number we are unable to review the device history record to determine if any deviations took place during the manufacture of this device. No sample was provided. Without the actual sample, we are unable to confirm what the customer experienced, and cannot determine a root cause for the reported issue. We will continue to monitor for complaints of this nature.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423537-2013-00012 |
| MDR Report Key | 2991026 |
| Report Source | 01,07 |
| Date Received | 2013-03-06 |
| Date of Report | 2013-03-06 |
| Date of Event | 2013-01-30 |
| Date Mfgr Received | 2013-02-07 |
| Date Added to Maude | 2013-03-07 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHELE DONATICH |
| Manufacturer Street | 1430 WAUKEGAN ROAD |
| Manufacturer City | MCGAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8478876412 |
| Manufacturer G1 | CARDINAL HEALTH 200, LLC |
| Manufacturer Street | 1430 WAUKEGAN RD |
| Manufacturer City | WAUKEGAN 60085 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60085 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRAPE,TAPE,ADHESVIE,4INX18IN |
| Generic Name | DRAPE, ADHESIVE, AEROSOL |
| Product Code | KGT |
| Date Received | 2013-03-06 |
| Catalog Number | A3524 |
| Lot Number | NO LOT GIVEN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | MCGAW PARK IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-03-06 |