MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2015-11-25 for PROVOX SILICONE GLUE 7720 manufactured by Atos Medical Ab.
[32100898]
The silicone glue was investigated. Nothing strange was found and glue had a full functionality. The viscosity of the glue was found to be normal. Patient photo shows skin irritation/discomfort around the stoma. Reactions to adhesives sometimes occur. In manual under caution, it can be read how to do when the user has skin irritation or other discomfort. Conclusion: no product error. Inform the user not to use the product when skin irritation or other discomfort occurs.
Patient Sequence No: 1, Text Type: N, H10
[32100899]
After using the glue the patient felt that it was burning on her skin. The glue was more viscous than the other glue she had before. The patient has a "burn" wound.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8032044-2015-00009 |
| MDR Report Key | 5249521 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2015-11-25 |
| Date of Report | 2015-11-25 |
| Date Mfgr Received | 2015-10-23 |
| Device Manufacturer Date | 2015-05-01 |
| Date Added to Maude | 2015-11-25 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR FERENC DAHNER |
| Manufacturer Street | PO-BOX 183 |
| Manufacturer City | HORBY, SE-242 22 |
| Manufacturer Country | SW |
| Manufacturer Postal | SE-242 22 |
| Manufacturer Phone | 415 19800 |
| Manufacturer G1 | ATOS MEDICAL AB |
| Manufacturer Street | PO BOX 183 KRAFTGATAN 8 |
| Manufacturer City | HORBY, SE-242 22 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | SE-242 22 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROVOX SILICONE GLUE |
| Generic Name | ADHESIVE GLUE |
| Product Code | GBJ |
| Date Received | 2015-11-25 |
| Returned To Mfg | 2015-11-05 |
| Catalog Number | 7720 |
| Lot Number | 1506120 |
| Device Expiration Date | 2020-01-06 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ATOS MEDICAL AB |
| Manufacturer Address | PO BOX 183 KRAFTGATAN 8 HORBY, SE-242 22 SW SE-242 22 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-11-25 |