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 2020-03-29 for UNKNOWN OPSITE POST OP manufactured by Smith & Nephew Medical Ltd..
[185727698]
It was reported that in a study that was trying to determine the effect of a? No drains? Policy on seroma formation and other complications in women undergoing breast cancer surgery and in which all surgical procedures were performed under general anaesthetic and the surgical technique is standardised, wounds are dressed with?? White steri-strips (nexcare) and a transparent waterproof dressing with an absorbent lattice pad (opsite post op, smith & nephew plc). It was stated that 31 patients in the group of mastectomy and axillary lymph node dissection presented infections or infected seromas. In the mastectomy and sentinel lymph node biopsy or axillary node sampling 9 patients presented wound infections or infected seromas. Lastly in the axillary lymph node dissection and wide local excision group 9 patients presented wound infections or infected seromas.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8043484-2020-00236 |
| MDR Report Key | 9896233 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-29 |
| Date of Report | 2020-03-29 |
| Date Mfgr Received | 2020-03-03 |
| Date Added to Maude | 2020-03-29 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | UNKNOWN OPSITE POST OP |
| Generic Name | TAPE AND BANDAGE, ADHESIVE |
| Product Code | KGX |
| Date Received | 2020-03-29 |
| Catalog Number | UNKNOWN |
| 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 | 2020-03-29 |