MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04 report with the FDA on 2011-10-28 for CONSEAL 50MM PLUGS, SHORT 0148501030 manufactured by Coloplast A/s.
[2224998]
An end user reported using a conseal (b)(4), and when she took it out the foam detached from the plate. The conseal was still in the bowels, and she could not get it out. The morning after, the patient irrigated but the conseal was still in the bowels. She got a time on the hospital for endoscopy but the same afternoon the conseal plug came out by itself. The patient only used the conseal plug shorter times when she did a workout with max weartime 4 hours. The patient has got the prescription for the plugs on (b)(6), 2011. She has thrown the box away so she has no lot number. The patient has had the conseal plug in her handbag and the other one that she has had in her handbag she has sent as a sample.
Patient Sequence No: 1, Text Type: D, B5
[2497289]
An end user reported using a conseal (b)(4), and when she took it out the foam detached from the plate. The conseal was still in the bowels, and she could not get it out. The morning after, the patient irrigated but the conseal was still in the bowels. She got a time on the hospital for endoscopy but the same afternoon the conseal plug came out by itself. The patient only used the conseal plug shorter times when she did a workout with max weartime 4 hours. The patient has got the prescription for the plugs on (b)(4), 2011. She has thrown the box away so she has no lot number. The patient has had the conseal plug in her handbag and the other one that she has had in her handbag she has sent as a sample.
Patient Sequence No: 1, Text Type: D, B5
[9522052]
One sample was received. Examination of the conseal 50mm plug revealed the foam detached because the conseal pin was broken. The root cause was not found. As no lot number was provided, relevant documentation could not be reviewed; however, no similar complaints have been received to date for this product.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006606901-2011-00037 |
| MDR Report Key | 2313834 |
| Report Source | 01,04 |
| Date Received | 2011-10-28 |
| Date of Report | 2011-10-03 |
| Date of Event | 2011-10-03 |
| Date Mfgr Received | 2011-10-03 |
| Date Added to Maude | 2011-10-31 |
| 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 | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | REBEKA STOLTMAN -- RA MANAGER |
| Manufacturer Street | 1601 WEST RIVER ROAD NORTH |
| Manufacturer City | MINNEAPOLIS MN 55411 |
| Manufacturer Country | US |
| Manufacturer Postal | 55411 |
| Manufacturer Phone | 6123024997 |
| Manufacturer G1 | COLOPLAST HUNGARY, KFT |
| Manufacturer Street | COLOPLAST UTCA 2 |
| Manufacturer City | NYIRBATOR, 4300 |
| Manufacturer Country | HU |
| Manufacturer Postal Code | 4300 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONSEAL 50MM PLUGS, SHORT |
| Generic Name | OSTOMY PLUG - ACCESSORY |
| Product Code | EZS |
| Date Received | 2011-10-28 |
| Returned To Mfg | 2011-10-05 |
| Model Number | 0148501030 |
| Catalog Number | 0148501030 |
| Lot Number | UNKNOWN |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COLOPLAST A/S |
| Manufacturer Address | HOLTEDAM-1 HUMLEBAEK, 3050 DA 3050 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-10-28 |