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..
[4642782]
Organogenesis, inc. Was notified of the event on (b)(4) 2013 via medical inquiry. Event description: on (b)(6) 2013, (b)(4) was notified by (b)(6) regarding a male patient who received two apligraf applications, one on (b)(6) 2013 and the second on (b)(6) 2013. Following each of his apligraf applications, was placed on bactrim for cellulitis. Attempts were made to obtain additional information from (b)(6) regarding the actual diagnosis, history of the presenting condition, co-morbidities, concomitant medications and the reported outcome. This male patient of undetermined age (initials and date of birth unknown) was being treated by dr (b)(6) for a right lower leg extremity wound (type, exact location and wound duration unknown). Details regarding wound bed preparation were not available. No details were available regarding the apligraf appearance or its application or post apligraf wound dressings or adjunct wound therapy. On (b)(6) 2013, this male patient had apligraf applied to his right lower extremity (type, exact location and duration of wound unknown). On (b)(6) 2013, the patient was placed on bactrim for "cellulitis in the area. " on (b)(6) 2013, the patient has apligraf applied again. On (b)(6) 2013, the patient was again started on bactrim for cellulitis. No additional information was provided. Per (b)(6), dr (b)(6) does not known if the events "were actually related to apligraf or not. "
Patient Sequence No: 1, Text Type: D, B5
[12051057]
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 (b)(4) 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. Apligraf lot #gs1301. 29. 05. 1a ((b)(4)) was packaged on (b)(4) 2013 and transferred to shipping on (b)(4) 2013, the lot met all specifications and release criteria for shipment. 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 (b)(4) 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 | 1221816-2014-00002 |
| MDR Report Key | 3946449 |
| Report Source | 00,05,06 |
| Date Received | 2014-07-11 |
| Date of Report | 2014-07-11 |
| Date of Event | 2013-04-26 |
| Date Mfgr Received | 2013-04-26 |
| Device Manufacturer Date | 2013-02-18 |
| 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 | GS1301.29.05.1A |
| Device Expiration Date | 2013-03-06 |
| 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 | CANTON MA 02021 US 02021 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-07-11 |