MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2020-02-04 for SURGIFOAM AGS, SZ 12-7 1972 manufactured by Ferrosan Medical Devices.
[177599450]
Product complaint # (b)(4). Attempts have been made to retrieve the device. 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. The single complaint was reported with multiple events. There are no additional details regarding the additional events. 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. Is this a male or female patient? What is the age of the patient? What surgical procedure did the patient undergo? And on what date? What symptoms did the patient have that required the patient to undergo this specific surgical procedure? Has the patient undergone previous similar surgery? If yes, on what date? Any complications following this surgery? For what purpose was the surgifoam sponge size 12-7 used during the surgery? Please be as detailed as possible. How was the surgifoam sponge size 12-7 used during the surgery: was the full piece used? How much of the surgifoam sponge was used? Was the surgifoam sponge used dry? Was the surgifoam sponge used in combination with thrombin solution? Was the surgifoam sponge used in combination with other fluids? Was the surgifoam sponge removed following the completion of the procedure? On what date did the patient return with symptoms referred to as? Product is not melting causing pain and infection in patients?? How was it identified that? Product is not melting?? Did the patient undergo any surgery or treatment? Please let us know in details where was the infection? How is the patient doing now? Are the patients from the same hospital facility? Are the patients from one or several physicians? Has the hospital facility just started to use surgifoam sponge for this specific procedure? If no, what did the hospital facility used before using surgifoam sponge for this type of surgical procedure? Please clarify the exact number of patients that experienced pain and or infection. Were cultures performed? If yes, results? Please confirm that the product is returning for evaluation?
Patient Sequence No: 1, Text Type: N, H10
[177599451]
It was reported that a patient underwent an unknown procedure on an unknown date and an absorbable hemostat was used. Post-operatively, the product is not melting causing pain and infection in the patient. Additional information was requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2020-70001 |
| MDR Report Key | 9664484 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2020-02-04 |
| Date of Report | 2020-01-06 |
| Date of Event | 2019-10-31 |
| Report Date | 2020-01-09 |
| Date Reported to Mfgr | 2020-01-09 |
| Date Mfgr Received | 2020-02-07 |
| Date Added to Maude | 2020-02-04 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | 3 |
| Brand Name | SURGIFOAM AGS, SZ 12-7 |
| Generic Name | ABSORBABLE, HEMOSTATIC |
| Product Code | LMF |
| Date Received | 2020-02-04 |
| Model Number | 1972 |
| Catalog Number | 1972 |
| Lot Number | 258028 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FERROSAN MEDICAL DEVICES |
| Manufacturer Address | SYDMARKEN 5 DK-2860 SOEBORG DA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-04 |