MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-19 for PROVOX LUNA ADHESIVE 8014 manufactured by Atos Medical Ab.
[95811757]
Investigation: no product was returned from customer. Provox luna adhesive, ref 8014, lot number was not available. Since no product was returned we cannot determine the reason why the adhesive had covered the stoma. Therefore this investigation is only theoretical. The hydrogel used in luna adhesive is known to be a material that absorbs moist/sweat very well and still having the adhesion to the skin. But if the water content is very high or very low the adhesion to the skin will decrease. In this complaint the user had the flu and much moist/sweat. This might be the reason to why the adhesive became loose and covered the stoma. The hydrogel material has a water activity of 53-61% according to the technical data sheet. If the adhesive is kept outside the intended diffusion sealed plastic bag the adhesive gets a lower adhesion because of the lower water content. According to luna ifu, contraindications: "the product shall not be used by patients with a decreased level of consciousness, patients with reduced mobility of the arms and/or hands, or patients who are unable to remove the device themselves. " -the user should always be able to remove the adhesive by himself/herself. The user has followed the instructions before the adhesive was applied. No body lotion or creams were used. No product error.
Patient Sequence No: 1, Text Type: N, H10
[95811758]
This is the information that was received from the atos medical local representative: husband followed instructions and placed luna onto his wife. Patient woke in the middle of the night and the base plate had covered her stoma. After further discussions the patients husband informed me that they both had flu and were experiencing night sweats. Additional info:? Was the skin cleaned before the adhesive was applied? Yes, husband cleans the skin every time with atos wipes, he has been doing this for 14 years and does everything by the book. ? If the skin was cleaned what cleaning products was used? Atos wipes. ? Was body lotion or other moisturizing creams used on the skin around the stoma? No - absolutely definitely no lotions or creams used. Pt didn't have radiotherapy so skin is in very good condition. ? Was this the first time the customer used luna or has she used it before? Any previous experience? This was the first time the patient had tried luna, she has had no other experiences. No product will be returned for investigation
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8032044-2017-00014 |
| MDR Report Key | 7127936 |
| Date Received | 2017-12-19 |
| Date of Report | 2017-11-28 |
| Date of Event | 2017-11-28 |
| Date Mfgr Received | 2017-11-28 |
| Date Added to Maude | 2017-12-19 |
| 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 | MS. KAROLINA NILSSON |
| Manufacturer Street | KRAFTGATAN 8 |
| Manufacturer City | HORBY, SE-24222 |
| Manufacturer Country | SW |
| Manufacturer Postal | SE-24222 |
| Manufacturer G1 | ATOS MEDICAL AB |
| Manufacturer Street | KRAFTGATAN 8 |
| Manufacturer City | HORBY, SE-24222 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | SE-24222 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PROVOX LUNA ADHESIVE |
| Generic Name | STOMAL APPLIANCE SKIN-ADHERENT PATCH, NON-STERILE |
| Product Code | KOX |
| Date Received | 2017-12-19 |
| Catalog Number | 8014 |
| Lot Number | UNKNOWN |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ATOS MEDICAL AB |
| Manufacturer Address | KRAFTGATAN 8 HORBY, SE-24222 SW SE-24222 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2017-12-19 |