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 2020-02-04 for SURGICEL POWDER USA - ABSORBABLE HEMOSTATIC PWDR 3013SP manufactured by Ethicon Inc..
[185915459]
Product complaint # (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. The patient demographic info: age, gender, weight, bmi at the time of index procedure? Date and name of index surgical procedure? The diagnosis and indication for the index surgical procedure? Relevant patient history? Any concurrent use of other products? Product code and 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? Were cultures performed? If yes, results? 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 infection? Post-operative hematoma? What is the patient? S current status? If applicable, will product be returned, return date, tracking information? What post-operative antibiotics or other medications were prescribed for the patient? S treatment? Do the patients routinely receive pre-op or post-op antibiotics? Has the pre or post operative treatment changed as a result of changing from arista to surgicel?
Patient Sequence No: 1, Text Type: N, H10
[185915460]
It was reported that a patient underwent a robotic hysterectomy on an unknown date and an absorbable hemostat was used. The surgeon said he switched brands of absorbable hemostat recently and the patient developed an infection. The surgeon used the absorbable hemostat prophylactically for blanket coverage and did not remove the excess. He also used an amniotic tissue membrane on the vaginal cuff and seprafilm when closing. The patient experienced a fever and had to go to the er post surgery. The patient did not experience a post-op device malfunction. The patient did not require revision surgery or hardware removal. The patient received post op antibiotics. Additional information was requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2020-00919 |
| MDR Report Key | 9665973 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-04 |
| Date of Report | 2020-01-17 |
| Date of Event | 2019-12-07 |
| Date Mfgr Received | 2020-02-13 |
| Date Added to Maude | 2020-02-04 |
| 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 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 | 2020-02-04 |
| Model Number | 3013SP |
| Catalog Number | 3013SP |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2020-02-04 |