MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2011-05-16 for GIZMO MEDIUM 5055301400 manufactured by Coloplast A/s.
[15579934]
According to the info received the user's wife called and stated that the double sided adhesive strip was so strong that when he tried to pull it off, it got stuck and had to go to the doctor to get it cut off. The tape had cut off circulation to the penis.
Patient Sequence No: 1, Text Type: D, B5
[15944332]
The product was not available to be returned. 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 add'l info be received, a f/u report will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005945907-2011-00011 |
| MDR Report Key | 2367637 |
| Report Source | 04 |
| Date Received | 2011-05-16 |
| Date of Report | 2011-04-18 |
| Date of Event | 2011-02-15 |
| Date Mfgr Received | 2011-04-18 |
| Date Added to Maude | 2011-12-14 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 (CHINA) CO., LTD. |
| Manufacturer Street | LOT NO.10, ZHUHAI FREE TRADE ZONE |
| Manufacturer City | ZHUHAI, GUANGDONG 519030 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 519030 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GIZMO MEDIUM |
| Generic Name | MALE EXTERNAL CATHETER, PRODUCT CODE: EXJ |
| Product Code | EXJ |
| Date Received | 2011-05-16 |
| Model Number | 5055301400 |
| Catalog Number | 5055301400 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COLOPLAST A/S |
| Manufacturer Address | HUMLEBAEK 3050DA 3050 DA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-05-16 |