MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,litera report with the FDA on 2020-03-29 for UNKNOWN OPSITE POST-OP manufactured by Smith & Nephew Medical Ltd..
[185902060]
It was reported that during a study which was comparing 3 different types of vaccination site bandages over time among both vaccinia-naive and vaccinia-experienced volunteers with respect to recovery of vaccinia, reactogenicity, tolerability, and ease of use. After vaccination, each volunteer was randomized to receive 1 of 3 types of vaccination site bandage: a 5#5-cm gauze bandage (curity gauze sponges sterile) attached with a single strip of adhesive tape, a 6. 5#5-cm semipermeable occlusive bandage with a gauze lining (opsite post-op), or a 7. 5#7. 5-cm foam hydrocellular bandage (allevyn adhesive). It was reported that some patients in the occlusive bandage (opsite post-op) loosening of the bandage during showering or sleeping.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8043484-2020-00230 |
| MDR Report Key | 9896218 |
| Report Source | COMPANY REPRESENTATIVE,LITERA |
| 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 |