MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2009-01-29 for MCGUIRE URINAL UNISIZE 5070701400 manufactured by Coloplast Manufacturing Us, Llc.
[1046984]
An end-user's daughter reported an issue with the product she had purchased for her father in early 2009. He used it that night along with a bardia bag (prod. Not lot number available). When he woke up, the sheath was suctioning around the penis so that it was almost completely flattened. When they removed the mcguire, the penis was swollen to almost 3 times the normal size and broken blood vessels were visible. There was very little urine in the collection bag, but patient's daughter reported they had used that exact bardia bag for 2 weeks with mecs and did not have an issue with it, so it didn't appear to be a defect in the bag. Patient claims he is not in pain, but may decide to go to urgent care if the swelling does not go down. A complaint was filed and patient is sending defective product back.
Patient Sequence No: 1, Text Type: D, B5
[8253413]
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, an addendum to this report will be filed. To date, no other complaints have been recorded for this lot number.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183558-2009-00004 |
| MDR Report Key | 1343300 |
| Report Source | 04 |
| Date Received | 2009-01-29 |
| Date of Report | 2009-01-08 |
| Date of Event | 2009-01-08 |
| Date Mfgr Received | 2009-01-08 |
| Date Added to Maude | 2009-08-31 |
| 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 | REBEKA STOLTMAN, MANAGER |
| Manufacturer Street | 1499 WEST RIVER RD N |
| 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 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MCGUIRE URINAL UNISIZE |
| Generic Name | URINE COLLECTOR |
| Product Code | FNP |
| Date Received | 2009-01-29 |
| Model Number | 5070701400 |
| Catalog Number | 5070701400 |
| Lot Number | 1578320 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COLOPLAST MANUFACTURING US, LLC |
| Manufacturer Address | MINNEAPOLIS MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-01-29 |