MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05,06 report with the FDA on 2014-07-11 for APLIGRAF manufactured by Organogenesis Inc..
[4645497]
On (b)(6) 2013, while (b)(4), manager drug safety and pharmacovigilance, organogenesis inc. (oi) was notified by (b)(6) rn, b. S. On behalf of dr. (b)(6) for wound healing, (b)(6) regarding a female patient who received apligraf applied to both her left and right lower extremities (wound type(s), location, and duration unknown) on (b)(6) 2013. At the time of this (b)(6) 2013 apligraf application, the patient was placed on clindamycin to "reduce bioburden" (i. E. , for prophylactically). On (b)(6) 2013, the patient had a second application of apligraf to both of her lower extremities. On (b)(6) 2013, when the patient presented to the clinic for her "regular" wound care visit, erythema and purulent drainage was noted on her right lower extremity wound. She was placed on clindamycin for 7 days. She did have a culture and sensitivity done, but results were unknown/not provided at this time. No additional information was known at this time. Per ms. Hill, dr. (b)(6) does not know if the events "were actually related to apligraf or not. "
Patient Sequence No: 1, Text Type: D, B5
[11981249]
Apligraf lot # gs1212. 27. 01. 1a (unit # unconfirmed from customer) was packaged on (b)(4) 2013 and transferred to shipping on (b)(4) 2013. 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 specifications at 10 days post airlift ((b)(6) 2013) and histology testing documentation was reviewed by qa on (b)(4) 2013. All final sterility and mycoplasma results were negative. Additionally, endotoxin testing results passed. The lot met all specifications and release criteria for shipment.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1221816-2014-00003 |
| MDR Report Key | 3946450 |
| Report Source | 00,05,06 |
| Date Received | 2014-07-11 |
| Date of Report | 2014-07-11 |
| Date of Event | 2014-04-11 |
| Date Mfgr Received | 2013-04-26 |
| Device Manufacturer Date | 2013-01-22 |
| Date Added to Maude | 2014-07-22 |
| 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 |
| 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 | 2014-07-11 |
| Lot Number | GS1212.27.01.1A |
| Device Expiration Date | 2013-02-01 |
| 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 | CANTON MA 02021 US 02021 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-07-11 |