MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-09-05 for DERMAGRAFT manufactured by Organogenesis Inc..
[20456145]
This mdr is being submitted for patient 1 of 3 for this complaint. On (b)(6) 2014, organogenesis tissue regeneration specialist (trs) reported to (b)(4), organogenesis medical science liaison (msl), on behalf of the treating physician at the (b)(6), dr. (b)(6), that patients who were treated with dermagraft (dg) applications had suspected infections. Subsequent follow up by (b)(4), on (b)(6) 2014 determined that three suspected infections were observed. Each was accompanied with a foul odor and increased drainage when subjects came in for their one-week follow up appointments on (b)(6) 2014. Dr. (b)(6) was skeptical to continue using this lot as he though it was possible that dg caused the presentation of infections. Each of these patient was treated with one dg for the treatment of diabetic foot ulcers. These units were from dg lot #147049 unit numbers unknown, and expiration date october 10, 2014. Based upon the description of the infections and the positive response to antibiotic, the severity of these events may be considered as moderate. This lot was shipped to 280 site without a single additional complaint. All manufacturing and testing documentation was reviewed and no atypical events were recorded that might explain the infections observed. The negative sterility test results on the retain samples validated that the integrity of the product remained free from microorganisms as it was in the original release. A potential root cause of the infection could be from a preexisting microbial contamination of the wound bed. Another potential root cause of this event would be if these units were contaminated by a common cause during thawing, rinsing or application at the (b)(6) site. Although there is substantial evidence to support that the use of dg is unlikely the cause of infections, relatedness cannot be completely ruled out for these 3 applications.
Patient Sequence No: 1, Text Type: D, B5
[20564032]
The three suspected infections were cultured and with positive results. Dr. (b)(6) did not have the results of the culturing to report what organism(s) were identified. All three patients did present with the signs and symptoms of infection. All three patients were given appropriate antibiotics and further dg treatment was delayed. The three patients with the suspected infections returned for a 1 week follow-up and they were all responding well to the antibiotics that were prescribed. Dr. (b)(6)'s plan is to resume dg treatment with each of these patients upon receipt of replacement dg units. The available information for this medical event was reviewed by dr. (b)(6), (b)(4) on (b)(6) 2014. The infections confirmed via culture at the treating site required intervention as antibiotics were prescribed. From the information provided, it is unclear what caused the signs and symptoms associated with infection or if the microorganisms were already present in the diabetic ulcer pre treatment. Dr. (b)(6) reported that 1 week following an antibiotic regimen, that all three patients improved and he stated they "responded well to the antibiotic".
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2028403-2014-00001 |
| MDR Report Key | 4098133 |
| Report Source | 07 |
| Date Received | 2014-09-05 |
| Date of Report | 2014-09-05 |
| Date of Event | 2014-08-07 |
| Date Mfgr Received | 2014-08-07 |
| Device Manufacturer Date | 2014-04-01 |
| Date Added to Maude | 2014-09-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | PATRICK BILBO |
| Manufacturer Street | 150 DAN RD. |
| Manufacturer City | CANTON MA 02021 |
| Manufacturer Country | US |
| Manufacturer Postal | 02021 |
| Manufacturer Phone | 7814011155 |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DERMAGRAFT |
| Product Code | PFC |
| Date Received | 2014-09-05 |
| Lot Number | 147049 |
| Device Expiration Date | 2014-10-10 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORGANOGENESIS INC. |
| Manufacturer Address | LA JOLLA CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-09-05 |