MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-10 for ETHICON, INC. PRINEO SKIN CLOSURE SYSTEM SURGICAL SEALANT MPH256 manufactured by Ethicon, Inc..
Report Number | MW5089716 |
MDR Report Key | 8992625 |
Date Received | 2019-09-10 |
Date of Report | 2019-09-08 |
Date of Event | 2019-05-14 |
Date Added to Maude | 2019-09-11 |
Event Key | 0 |
Report Source Code | Voluntary report |
Manufacturer Link | N |
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 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 0 |
Brand Name | ETHICON, INC. PRINEO SKIN CLOSURE SYSTEM SURGICAL SEALANT |
Generic Name | CUTANEOUS TISSUE ADHESIVE WITH MESH |
Product Code | OMD |
Date Received | 2019-09-10 |
Catalog Number | MPH256 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | I |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | ETHICON, INC. |
Manufacturer Address | SOMERVILLE NJ 08876 US 08876 |
Brand Name | ETHICON, INC. PRINEO SKIN CLOSURE SYSTEM SURGICAL SEALANT |
Generic Name | CUTANEOUS TISSUE ADHESIVE WITH MESH |
Product Code | OMD |
Date Received | 2019-09-10 |
Catalog Number | MPH056 |
Device Availability | * |
Device Eval'ed by Mfgr | I |
Device Sequence No | 2 |
Device Event Key | 0 |
Manufacturer | ETHICON, INC. |
Manufacturer Address | SOMERVILLE NJ 08876 US 08876 |
Brand Name | ETHICON, INC. PRINEO SKIN CLOSURE SYSTEM SURGICAL SEALANT |
Generic Name | CUTANEOUS TISSUE ADHESIVE WITH MESH |
Product Code | OMD |
Date Received | 2019-09-10 |
Catalog Number | MMJ779 |
Device Availability | * |
Device Eval'ed by Mfgr | I |
Device Sequence No | 3 |
Device Event Key | 0 |
Manufacturer | ETHICON, INC. |
Manufacturer Address | SOMERVILLE NJ 08876 US 08876 |
Brand Name | ETHICON, INC. PRINEO SKIN CLOSURE SYSTEM SURGICAL SEALANT |
Generic Name | CUTANEOUS TISSUE ADHESIVE WITH MESH |
Product Code | OMD |
Date Received | 2019-09-10 |
Catalog Number | MPH208 |
Device Availability | * |
Device Eval'ed by Mfgr | I |
Device Sequence No | 4 |
Device Event Key | 0 |
Manufacturer | ETHICON, INC. |
Manufacturer Address | SOMERVILLE NJ 08876 US 08876 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2019-09-10 |