MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2017-10-26 for ALLEVYN GENTLE BRD SACRUM CT10 66801031 manufactured by Smith & Nephew Medical Ltd..
[90326553]
Patient Sequence No: 1, Text Type: N, H10
[90326554]
It was reported patient has developed bed sores after using allevyn.
Patient Sequence No: 1, Text Type: D, B5
[109155320]
Please review attached for investigation results. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8043484-2017-00259 |
| MDR Report Key | 6979786 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2017-10-26 |
| Date of Report | 2018-01-16 |
| Date of Event | 2017-10-06 |
| Date Mfgr Received | 2017-10-13 |
| Date Added to Maude | 2017-10-26 |
| 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 | MR MARKUS POETTKER |
| Manufacturer Street | SCHACHENALLEE 29 |
| Manufacturer City | AARAU 5001 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 5001 |
| Manufacturer G1 | SMITH & NEPHEW MEDICAL LTD. |
| Manufacturer Street | NO.12 WUXIANG ROAD. COMPREHENSIVE FREE ZONE WEST Z |
| Manufacturer City | SUZHOU 215021 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 215021 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALLEVYN GENTLE BRD SACRUM CT10 |
| Generic Name | BANDAGE, LIQUID |
| Product Code | KMF |
| Date Received | 2017-10-26 |
| Model Number | 66801031 |
| Catalog Number | 66801031 |
| Lot Number | 201709 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW MEDICAL LTD. |
| Manufacturer Address | 101 HESSLE ROAD HULL HU32BN UK HU32BN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-26 |