MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-12 for SURGICEL POWDER USA - ABSORBABLE HEMOSTATIC PWDR 3013SP manufactured by Ethicon Inc..
[184811811]
(b)(4). To date the device has not been returned. If the device or further details are received at a later date a supplemental medwatch will be sent. Attempts are being made to obtain the following information. To date no response has been provided. If further details are received at a later date a supplemental medwatch will be sent. What were the exact post-op concerns for the patients that underwent a partial nephrectomy? Additionally, for each patient please provide the following information: the patient demographic info: age, gender, weight, bmi at the time of index procedure? Date of index surgical procedure? The diagnosis and indication for the index surgical procedure? Relevant patient history? Any concurrent use of other products? Lot #? What was the intended use of the surgicel? Where was the surgicel used (on what tissue)? How much surgicel was used during the procedure? Was the surgicel product left in place? Was the excess irrigated and removed? What were current symptoms following the index surgical procedure? Onset date? Has any surgical or medical intervention been performed? What is physician? S opinion as to the etiology of or contributing factors to this event? Was there an alleged deficiency of the surgicel that contributed to the patient? S post-operative anastomotic leak? What is the patient? S current status?
Patient Sequence No: 1, Text Type: N, H10
[184811812]
It was reported that a patient underwent a prostatectomy procedure on an unknown date and an absorbable hemostat was used. The surgeon did not irrigate or remove excess. Several days post op, the patient presented with leak at the anastomotic site of the urethra. A catheter was placed in the patient and the anastomotic leak was stented for treatment. The only change the surgeon made was switching from arista. The patient's status is unknown. Additional information was requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2020-01142 |
| MDR Report Key | 9701717 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-12 |
| Date of Report | 2020-01-16 |
| Date of Event | 2019-01-01 |
| Date Mfgr Received | 2020-01-16 |
| Date Added to Maude | 2020-02-12 |
| 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 | KARA DITTY-BOVARD |
| Manufacturer Street | P.O. BOX 151, ROUTE 22 WEST |
| Manufacturer City | SOMERVILLE NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | ETHICON INC.-SAN LORENZO PR |
| Manufacturer Street | ROAD 183, KM. 8.3 |
| Manufacturer City | SAN LORENZO 00754 |
| Manufacturer Country | * |
| Manufacturer Postal Code | 00754 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SURGICEL POWDER USA - ABSORBABLE HEMOSTATIC PWDR |
| Generic Name | AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED |
| Product Code | LMG |
| Date Received | 2020-02-12 |
| Model Number | 3013SP |
| Catalog Number | 3013SP |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON INC. |
| Manufacturer Address | P.O. BOX 151, ROUTE 22 WEST SOMERVILLE NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-12 |