MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04,08 report with the FDA on 2011-04-21 for CONVEEN SECURITY SSU 035 0523501017 manufactured by Coloplast A/s.
[2119354]
Patient identifier: (b)(6). Date of event: best estimate is (b)(6) 2011. According to the information received, it was reported that the packaging on the green bags were damaged-they were perforated. Also, the adhesive was so strong that part of the skin of the penis of the end user came off while trying to remove the urisheath.
Patient Sequence No: 1, Text Type: D, B5
[9194522]
Product has been requested but as of to date no product was returned. Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurence. Should additional information become available a follow-up report will be submitted. Follow up 1: returned product was tested using a peel adhesion test. The measured values for the testing were below the specification. Therefore, this complaint can be confirmed for weak adhesive but not the originally reported "strong adhesive".
Patient Sequence No: 1, Text Type: N, H10
[19272168]
(b)(6). According to the information received, it was reported that the packaging on the green bags were damaged-they were perforated. Also, the adhesive was so strong that part of the skin of the penis of the end user came off while trying to remove the urisheath.
Patient Sequence No: 1, Text Type: D, B5
[19447995]
Product has been requested but as of to date no product was returned. Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurence. Should additional information become available a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003814961-2011-00003 |
| MDR Report Key | 2065781 |
| Report Source | 01,04,08 |
| Date Received | 2011-04-21 |
| Date of Report | 2011-03-25 |
| Date Mfgr Received | 2011-03-25 |
| Device Manufacturer Date | 2010-10-18 |
| Date Added to Maude | 2011-04-21 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. BRIAN SCHMIDT |
| Manufacturer Street | 1601 WEST RIVER ROAD NORTH |
| Manufacturer City | MINNEAPOLIS MN 55411 |
| Manufacturer Country | US |
| Manufacturer Postal | 55411 |
| Manufacturer Phone | 6123024987 |
| Manufacturer G1 | COLOPLAST A/S |
| Manufacturer Street | COLOPLAST HUNGARY KFT BUZAVIRAG UT 15 |
| Manufacturer City | TATABANYA, HU 2800 |
| Manufacturer Country | HU |
| Manufacturer Postal Code | 2800 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONVEEN SECURITY SSU 035 |
| Generic Name | MALE EXTERNAL CATHETER UROSHEATH |
| Product Code | EXI |
| Date Received | 2011-04-21 |
| Model Number | 0523501017 |
| Catalog Number | 0523501017 |
| Lot Number | 2617904 |
| Device Expiration Date | 2011-11-30 |
| 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 A/S |
| Manufacturer Address | HUMLEBAEK, 3050 DA 3050 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-04-21 |