MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2006-12-20 for SORBSAN (WOUND DRESSING) NOT KNOWN NA manufactured by Unomedical, Ltd..
[541350]
Conversation: the pt reportedly began using the product in 2005. The nurse practitioner reported that the product was applied to the granuloma around the patient's g-tube site. Within 10 minutes of application, the patient's mother reported that the area had become red and irritated. The product was removed after being applied for approximately 30 minutes. The nurse practitioner informed me that within 24 hours the area of the application site became necrotic. The patient was admitted to the hospital 3 days later. She stated that the g-tube is non functioning and the patient has had a broviac catheter placed and is being started on hyperalimentation. The patient remains hospitalized. The nurse practitioner was unable to provide information regarding the treatment, if any, given to the site. Information regarding medical history and concomitant medications was provided. The nurse practitioner was transferred for additional information regarding the product. Physician contact information was provided and she's willing to complete and return a product experience form.
Patient Sequence No: 1, Text Type: D, B5
[8058397]
Unomedical has reviewed the biocompatibility data and have had an evaluation performed by the company's consultant physician. Unomedical has also reviewed the complaint file to establish the complaint ratio which relates to allergies associated with the sorbsan product. A review was also performed on the instructions for use in respect to this adverse event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010113-2006-00001 |
| MDR Report Key | 799258 |
| Report Source | 08 |
| Date Received | 2006-12-20 |
| Date of Report | 2006-12-14 |
| Date of Event | 2005-08-10 |
| Date Mfgr Received | 2005-11-02 |
| Date Added to Maude | 2007-01-03 |
| 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 | 0 |
| Manufacturer Contact | EFFRAIN CARRERO |
| Manufacturer Street | 5701-1 S. WARE RD |
| Manufacturer City | MCALLAN TX 78503 |
| Manufacturer Country | US |
| Manufacturer Postal | 78503 |
| Manufacturer Phone | 9566838472 |
| Manufacturer G1 | UNOMEDICAL LIMITED |
| Manufacturer Street | THORNHILL ROAD |
| Manufacturer City | REDDITCH, WORCESTERSHIRE B989NL |
| Manufacturer Country | UK |
| Manufacturer Postal Code | B98 9NL |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SORBSAN (WOUND DRESSING) |
| Generic Name | SORBSAN |
| Product Code | MGQ |
| Date Received | 2006-12-20 |
| Model Number | NOT KNOWN |
| Catalog Number | NA |
| Lot Number | NOT KNOWN |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 786776 |
| Manufacturer | UNOMEDICAL, LTD. |
| Manufacturer Address | * REDDITCH UK |
| Baseline Brand Name | SORBSAN (WOUND DRESSING) |
| Baseline Generic Name | SORBSAN |
| Baseline Model No | NOT KNOWN |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2006-12-20 |