MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-03-21 for APLIGRAF manufactured by Organogenesis Inc..
[139424662]
Although this event has been assessed by the treating clinician as possibly related and by the medical assessment of the organogenesis assessor as probably unrelated to the use of apligraf, organogensis has decided to submit this mdr as a conservative measure due to the moderate severity of the infection which resulted in hospitalization and intervention with iv antibiotics. This event did not result in death and was not life threatening. The event resolved and no permanent damage to body structure or permanent impairment of function has occurred as a result of the infection. This event is expected, as infection is a common complication with chronic wounds. All sterility, bioburden, endotoxin and histology testing of the lot passed specification and there have been no other complaints from this lot of apligraf.
Patient Sequence No: 1, Text Type: N, H10
[139424663]
On (b)(6) 2019, (b)(6) year old patient, mg, received application of apligraf on a wound originally caused by tripping on her walker on (b)(6) 2018. The original wound, a right lower extremity laceration was sutured in the er the same day, the patient was given a tetanus booster and ancef while in the er and discharged on a course of oral keflex. On (b)(6) 2018 the patient followed up in the wound care center and was found to have necrosis of the wound site and dehisced laceration. The patient was then treated weekly in the wound care center with serial debridements, dakin's solution and unna boot compression due to swelling. On (b)(6) 2019, the wound was improving with good granulation tissue and no signs of infection. On (b)(6) 2019, the wound was debrided and apligraf was applied on a portion of the wound since the wound was larger than the size of the apligraf. The apligraf was secured with steri-strips, covered with wound veil, saline moistened gauze and kling. On (b)(6)2019, the patient called the wound care center complaining of fevers and right lower extremity warmth and erythema and was told to go to the er. The patient was admitted with a diagnosis of right lower extremity cellulitis. The wound was cultured in three different locations, (1) over the apligraf, (2) on the portion of the wound that did not have the apligraf and (3) the wound bed where apligraf was applied (after removal). The patient was treated by an infectious disease doctor with iv vancomycin and zosyn during her admission. The apligraf was removed on (b)(6) 2019. The patient underwent a bedside incision and drainage and debridement by a general surgeon on (b)(6) 2019. The wound was treated locally with dakin's dressing throughout her hospitalization. The patient was discharged on (b)(6) 2019 on iv levaquin. The patient followed up at the wound care center on (b)(6) 2019 and the infection had completely resolved, and the wound was improving, with an area of some tunneling where the debridement was performed. The patient was still on iv levaquin and doing much better.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221816-2019-00001 |
| MDR Report Key | 8439432 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-03-21 |
| Date of Report | 2019-03-21 |
| Date of Event | 2019-02-28 |
| Date Mfgr Received | 2019-03-05 |
| Date Added to Maude | 2019-03-21 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR JOHN FERROS |
| Manufacturer Street | 150 DAN ROAD |
| Manufacturer City | CANTON MA 02021 |
| Manufacturer Country | US |
| Manufacturer Postal | 02021 |
| Manufacturer Phone | 7816151833 |
| Manufacturer G1 | ORGANOGENESIS INC. |
| Manufacturer Street | 150 DAN ROAD |
| Manufacturer City | CANTON MA 02021 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02021 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | APLIGRAF |
| Generic Name | APLIGRAF |
| Product Code | PFC |
| Date Received | 2019-03-21 |
| Lot Number | GS1901.29.03.1A |
| Device Expiration Date | 2019-03-09 |
| 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 | 150 DAN ROAD CANTON MA 02021 US 02021 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2019-03-21 |