MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04 report with the FDA on 2009-07-20 for FREEDOM CLEAR ADVANTAGE I 100 5043411400 manufactured by Coloplast Manufacturing Us, Llc.
[17073066]
According to the information received, an end user reported strong adhesive, stating that the adhesive from a box purchased is very abundant compared to the boxes previously purchased. User reported that, from one clear advantage to another, the adhesive (strength) differs and also reports getting sores from removal of the clear advantage because it adheres too much and tears the skin.
Patient Sequence No: 1, Text Type: D, B5
[17230800]
The return of the device has been requested. It is unknown if the device is still available. Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence. Should the device or additional information be received, a follow-up report will be filed. A review of the production records for this lot demonstrates that the peel strength test results were below the upper limits of the adhesiveness specification. Device not received by manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[19285646]
Date of event: 2009. According to the information received, an end user reported strong adhesive, stating that the adhesive from a box purchased is very abundant compared to the boxes previously purchased. User reported that, from one clear advantage to another, the adhesive (strength) differs and also reports getting sores from removal of the clear advantage because it adheres too much and tears the skin.
Patient Sequence No: 1, Text Type: D, B5
[19325300]
Product was subsequently received for evaluation, with samples inspected and tested for adhesive peel strength. The samples were found to meet adhesiveness specifications. Production records for this lot were examined, as well. A review of the production records for this lot demonstrates that the peel strength test results were below the upper limits of the adhesiveness specification. The records show all operations to be working normally at the time of manufacture with all inspections completed and passed. The products received conform with valid specifications. No other complaints have been recorded to date for this lot number.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183558-2009-00031 |
| MDR Report Key | 1416063 |
| Report Source | 01,04 |
| Date Received | 2009-07-20 |
| Date of Report | 2009-06-09 |
| Date Mfgr Received | 2009-06-09 |
| Date Added to Maude | 2009-11-13 |
| 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 | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | REBEKA STOLTMAN |
| Manufacturer Street | 1601 WEST RIVER ROAD NORTH |
| Manufacturer City | MINNEAPOLIS MN 55411 |
| Manufacturer Country | US |
| Manufacturer Postal | 55411 |
| Manufacturer Phone | 6123024997 |
| Manufacturer G1 | COLOPLAST MANUFACTURING US, LLC |
| Manufacturer Street | 1185 WILLOW LAKE BLVD |
| Manufacturer City | VADNAIS HEIGHTS MN 55110 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55110 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FREEDOM CLEAR ADVANTAGE I 100 |
| Generic Name | MALE EXTERNAL CATHETER |
| Product Code | EXJ |
| Date Received | 2009-07-20 |
| Model Number | 5043411400 |
| Catalog Number | 5043411400 |
| Lot Number | 53412199 |
| Device Expiration Date | 2011-03-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COLOPLAST MANUFACTURING US, LLC |
| Manufacturer Address | 1185 WILLOW LAKE BLVD VADNAIS HEIGHTS MN 55110 US 55110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-07-20 |