MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2013-05-02 for APLIGRAF manufactured by Organogenesis, Inc..
[3290690]
Organogenesis was notified of the event on (b)(6) 2013 via e-mail communication from clinical site. On (b)(6) 2013, (b)(4), quality affairs compliance specialist was notified by (b)(6), who, on (b)(6) 2013, had been notified by (b)(6), (b)(6) center, on behalf of dr (b)(6) or dr (b)(6) (unclear who prescribing physician was; this patient? S previous sepsis report ae # (b)(4) indicated dr (b)(6) had been caring for patient), (b)(6) center, (b)(6) medical center, regarding a patient who had apligraf applied to his lateral right ankle chronic venous stasis ulcer and was hospitalized for sepsis. On (b)(6) 2013, following his third apligraf application on (b)(6) 2013 (lot # gs1302. 26. 03. 1a, unit number unk), this patient, who had previously been hospitalized for sepsis, presented for his? Regular? (b)(6) center visit with a? Ridiculously low? Blood pressure,? Something like 56? Systolic, was sent to the emergency department (ed and was admitted to the hospital with sepsis. It is unclear whether his second, (b)(6) 2013, hospitalization for sepsis, was due to a second separate distinct event of sepsis or a continuation of his prior sepsis event (ae (b)(4); not related to apligraf) which occurred following his second apligraf application on (b)(6) 2013 and for which he was hospitalized (b)(6), 2013. Add? L info was obtained from (b)(6) center and (b)(6) center for wound healing regarding the actual diagnosis, history of the presenting condition, co-morbidities, concomitant medication and the reported event outcome. Patient, (b)(6) male has a medical history including chronic atrial fibrillation (af), chronic obstructive pulmonary disease (copd), hypertension, hypothyroidism, hypercholesterolemia, chronic kidney disease, peripheral vascular and chronic venous stasis ulcer lateral right ankle. He is allergic to? Sulfa? Drugs. Concomitant medications included daily pravastatin, lisinopril, toprol (metoprolol), vitamin d, digoxin, spironolactone, pristiq (desvenlafaxine) and predaxa; twice daily advair diskus (fluticasone proprionate) and torsemide; neurontin (gabapentin) and magnesium three times daily and xopenex (levalbuterol) inhaler as needed. This patient was being treated for a chronic venous stasis ulcer on his right lower leg that he? D had for ten years (on and off, wound healed then opened, healed then opened, etc. ) previous treatments reported included? Vac? On the wound (per patient). He did not have wound grafts in the past. No other info regarding any past wound treatments was provided. Prior to beginning apligraf applications, wound dimensions (cm) were 10. 1x5. 7x0. 5. It was confirmed that the patient has had a total of three apligraf applications to his lateral right ankle chronic venous stasis ulcer: (b)(6) 2013 (wound dimensions (cm): 9. 8x 4. 9x0. 4; lot# gs1212. 27. 01. 1a; expiration date, february 1, 2013), (b)(6) 2013 (wound dimensions unk, lot # gs1301. 10. 02. 1a; expiration date, february 16, 2013) and (b)(6) 2013 (wound dimensions unk; (lot # gs1302. 26. 06. 1a, expiration date, april 3, 2013); there was no apligraf applied on (b)(6) 2013 as had previously been reported for this patient? S prior event of sepsis. No info regarding the patient? S third (b)(6) 2013 apligraf application was provided, e,g. , appearance, application process, post-apligraf dressings, etc. Previous info provided regarding the patient? S (b)(6) 2013 prior report of sepsis (b)(4) included: wound bed preparation included sharp debridement. The appearance or it's application process were not provided. Post-apligraf application, the wound was? Bolstered and covered with profore;? Post-apligraf dressings further described as:? Steri-strips, adaptic, saline two by two bolus and profore.? On (b)(6) 2013, following his (b)(6) 2013 (third) apligraf application, the patient presented to the (b)(6) clinic with a? Ridiculously low? Blood pressure,? Something like fifty-six? (systolic), was? Septic again? And was sent to the emergency room (er). This patient had previously been hospitalized on (b)(6) 2013 for sepsis and renal failure (ae (b)(4); assessed as not related to apligraf). Following his (b)(6) 2013 hospitalization, on (b)(6) 2013, the patient returned to the wound care clinic, reported he was feeling better and had his third apligraf application to his lateral right ankle chronic venous stasis ulcer. On (b)(6) 2013, the patient returned to the wound care clinic for his? Regular visit? And was found to have? Ridiculously low? Blood pressure,? Something like fifty-six? (systolic). He was sent to the emergency dept (ed) and admitted on the same day for sepsis. It was unk whether the sepsis resulting in this second (b)(6) 2013 admission was a continuation of the patient? S prior sepsis event/hospitalization ((b)(4); i. E. , unknown whether prior sepsis event had completely resolved, cleared). It was also unk whether any cultures were done. The (b)(6) 2013 hospitalization treatment included oral augmentin (amoxicillin and clavulanate) and flagl (metronidazole), both three time per day (tid) for 15 days. On (b)(6) 2013, the patient returned to the wound care clinic and did not have apligraf applied to his wound. He had dry gauze applied,? And nothing else.? On (b)(6) 2013, the patient was treated at the wound clinic with? Silver collagen and profore light.? It was unk which doctor had prescribed the patient? S third apligraf application as ms. Hill indicated that the wound care clinic director, dr (b)(6) had been treating the patient but currently, dr (b)(6) was treating the patient. For the prior event of sepsis (ae (b)(4)), it was reported that dr (b)(6) had been treating the patient with apligraf. Per (b)(6), it was unclear whether the patient? S doctor considered the (b)(6) 2013 sepsis event related to apligraf. No add? L info was provided.
Patient Sequence No: 1, Text Type: D, B5
[10697653]
(b)(4). Review of the device history record for this lot indicated the lot met all specifications and release criteria for shipment. There were no other complaints associated with the same lot.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1221816-2013-00002 |
| MDR Report Key | 3095143 |
| Report Source | 00 |
| Date Received | 2013-05-02 |
| Date of Report | 2013-04-03 |
| Date of Event | 2013-04-03 |
| Date Mfgr Received | 2013-04-03 |
| Device Manufacturer Date | 2013-02-01 |
| Date Added to Maude | 2013-05-08 |
| 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 | 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 |
| Manufacturer G1 | ORGANOGENESIS, INC. |
| Manufacturer Street | 150 DAN RD. |
| 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 | NA |
| Product Code | MGR |
| Date Received | 2013-05-02 |
| Lot Number | GS1302.26.03.1A |
| Device Expiration Date | 2013-04-03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORGANOGENESIS, INC. |
| Manufacturer Address | 150 DAN RD. CANTON MA 02021 US 02021 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2013-05-02 |