MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-30 for PICO 7 15CM X 15CM 66802005 manufactured by Smith & Nephew Medical Ltd..
[185902242]
It was reported that after orthopedic surgery in the trochanter, while the patient was using the pico dressing, it did not absorb the exudate which was accumulated in the surrounding skin, causing skin irritation and dermatitis. The dressing was applied for 5 days, and it had no visible sign of exudate in the absorbent layer. The customer replaced the pico and maintained the treatment. The skin was cleaned and protected with secura. No medical intervention needed, no patient harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8043484-2020-00239 |
| MDR Report Key | 9901631 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-04 |
| Date Mfgr Received | 2020-03-04 |
| Date Added to Maude | 2020-03-30 |
| 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 | DR SARAH FREESTONE |
| Manufacturer Street | 101 HESSLE ROAD |
| Manufacturer City | HULL HU3 2BN |
| Manufacturer Country | UK |
| Manufacturer Postal | HU3 2BN |
| Manufacturer Phone | 0447940038 |
| Manufacturer G1 | SMITH & NEPHEW MEDICAL LTD. |
| Manufacturer Street | 101 HESSLE ROAD |
| Manufacturer City | HULL HU3 2BN |
| Manufacturer Country | UK |
| Manufacturer Postal Code | HU3 2BN |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PICO 7 15CM X 15CM |
| Generic Name | NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP |
| Product Code | OMP |
| Date Received | 2020-03-30 |
| Catalog Number | 66802005 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW MEDICAL LTD. |
| Manufacturer Address | 101 HESSLE ROAD HULL HU3 2BN UK HU3 2BN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-30 |