MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-04-06 for APLIGRAF manufactured by Organogenesis.
[104663954]
Apligraf lot gs1406. 17. 04. 1a (unit 29) was packaged and transferred to shipping on 07/10/2014. Review of the device history record for this lot indicated that all required documentation and review signatures were completed prior to transfer of the lot to shipping. Histology samples from this lot met device specification at 10 days pal on (b)(6) 2014 and histology testing documentation was reviewed by qa on (b)(6) 2014. All final sterility, bioburden and mycoplasma results were negative. Endotoxin testing passed and was reviewed by qa on (b)(6) 2015. The lot met all specifications and release criteria for shipment. Mdr decision made as result of retrospective review of files in light of findings from an fda inspection.
Patient Sequence No: 1, Text Type: N, H10
[104663955]
On (b)(6) 2014 a call was received by (b)(6) (organogenesis qa supervisor) via the apligraf adverse event (ae) telephone reporting line from (b)(6), rn, case manager, (b)(6) wound care center on the behalf of dr. (b)(6), regarding a patient condition post apligraf application where the reporting nurse was "not positive that this was really an adverse event". Per the complaint questionaire, it was learned that the patient who had been treated with apligraf on (b)(6) 2014 for an ankle ulcer (lot # gs 1406. 17. 04. 1. A, unit number 29, expiration date july 25, 2014) presented for a follow up visit on (b)(6) 2014 and was found to have necrotic tissue on ankle and two wound sites. This patient had been treated for these same wounds approximately one year earlier and the reporting nurse said they "were fine". She also indicated that this patient was stable following this earlier apligraf treatment. It appeared that the wound observed on (b)(6) 2014, one week post initial treatment showed the presence of necrotic tissue. Swab cultures of the wound sites revealed normal skin flora and the reporting nurse indicated that the presence of these microbes in the wound site "may have had an impact on apligraf". This patient had their wounds debrided to the tendon and was then hospitalized and treated with antibiotics. Details regarding wound bed preparation were unknown/not reported. It was reported that apligraf was utilized per the instructions in the apligraf labeling. Prior to use, the apligraf had been stored in the validated shipper box and not opened until the procedure. There were no tears or holes reported in the bag containing the apligraf. Apligraf was within the required ph range prior to application and was used within 15 minutes of opening the bag. Saline was applied to the unit for less than 5 minutes and then the tool(s) used to initially to pull the apligraf unit away from the membrane was a cotton swab to tease it up and the unit was placed on gauze for transfer to patient for application. The unit was fenestrated via a blade and the size of the unit was cut to fit the wound sites with "small bit of overlap". No additional information regarding apligraf application and/or adjunctive wound therapies was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221816-2018-00001 |
| MDR Report Key | 7404482 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-04-06 |
| Date of Report | 2018-04-06 |
| Date of Event | 2014-07-25 |
| Date Mfgr Received | 2014-07-30 |
| Date Added to Maude | 2018-04-06 |
| 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 | 3 |
| Manufacturer Contact | PATRICK BILBO |
| Manufacturer Street | 150 DAN ROAD |
| Manufacturer City | CANTON MA 02021 |
| Manufacturer Country | US |
| Manufacturer Postal | 02021 |
| Manufacturer Phone | 7814011155 |
| 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 | 2018-04-06 |
| Lot Number | GS1406.17.04.1A |
| Device Expiration Date | 2014-07-25 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORGANOGENESIS |
| Manufacturer Address | 150 DAN ROAD CANTON MA 02021 US 02021 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2018-04-06 |