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 2019-04-26 for MEPILEX AG 287100 manufactured by Molnlycke Healthcare.
[143389038]
A report was received that a suspected burn wound infection and worsening in the wound status required a pediatric patient to be re-admitted to hospital for 6 days and successfully treated with systemic oral antibacterial treatment. The wound had been very close to being healed when the dressing was reapplied by the nurse at the end of the previoa report was received that a suspected burn wound infection and worsening in the wound status required a pediatric patient to be re-admitted to hospital for 6 days and successfully treated with systemic oral antibacterial treatment. The wound had been very close to being healed when the dressing was reapplied by the nurse at the end of the previous week. The nurse stated the dressing was used in accordance with the instructions for use and the patient had no prior history of similar issues. Request has been made for additional information.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004763499-2019-00005 |
| MDR Report Key | 8558490 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-04-26 |
| Date of Report | 2019-03-27 |
| Date of Event | 2019-03-27 |
| Date Mfgr Received | 2019-03-27 |
| Date Added to Maude | 2019-04-26 |
| 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 PAT STRAHL |
| Manufacturer Street | 5550 PEACHTREE PARKWAY SUITE 500 |
| Manufacturer City | NORCROSS GA 30092 |
| Manufacturer Country | US |
| Manufacturer Postal | 30092 |
| Manufacturer Phone | 4043750171 |
| Manufacturer G1 | MOLNLYCKE HEALTHCARE |
| Manufacturer Street | 5550 PEACHTREE PARKWAY SUITE 500 |
| Manufacturer City | NORCROSS GA 30092 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30092 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEPILEX AG |
| Generic Name | WOUND DRESSING |
| Product Code | NAC |
| Date Received | 2019-04-26 |
| Model Number | 287100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MOLNLYCKE HEALTHCARE |
| Manufacturer Address | 5550 PEACHTREE PARKWAY SUITE 500 NORCROSS GA 30092 US 30092 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Deathisabilit | 2019-04-26 |