MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-07-11 for APLIGRAF manufactured by Organogenesis, Inc..
[20456584]
On (b)(4) 2013, (b)(4), quality assurance compliance specialist, organogenesis inc. (oi), was notified via telephone by (b)(6), tissue regeneration specialist, 01, on behalf of dr. (b)(6), dpm, (b)(6)) hospital, (b)(6), regarding a male patient who had received five apligraf applications to his vlu "left foot/ankle. " following the patient's fifth apligraf application on an unknown date (lot# gs 1302. 21. 01. 1a, unit #75; prior apligraf dates, lot and unit numbers unknown), the patient presented on (b)(6) 2013 and was observed to have a generalized rash, assessed as a potential allergic reaction to apligraf. Additional information was obtained from (b)(6), tissue regeneration specialist, 01 on behalf of dr. (b)(6), (b)(6) hospital regarding the actual diagnosis and history of the presenting condition, co-morbidities, concomitant medications and the reported event outcome. This male patient of undetermined age (initials and date of birth unknown/not reported) was being treated by dr. (b)(6) for a venous leg ulcer (vlu) on his "left foot/ankle" (duration of wound not available). Per (b)(6), the patient had no reported rashes following his four prior apligraf applications (dates, lot numbers and unit numbers unknown/not provided). Patient comorbidities, concomitant medications and allergy history were unknown/not reported.
Patient Sequence No: 1, Text Type: D, B5
[20495022]
Apligraf lot# gs1302. 21. 01. 1a (unit # 75) was packaged on 03/19/2013 and transferred to shipping on 03/19/2013. 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 12 days post airlift (03/15/2013) and histology testing documentation was reviewed by qa on 03/18/2013. 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 | 1221816-2014-00001 |
| MDR Report Key | 3946448 |
| Report Source | 07 |
| Date Received | 2014-07-11 |
| Date of Report | 2014-07-11 |
| Date of Event | 2013-04-04 |
| Date Mfgr Received | 2013-04-04 |
| Device Manufacturer Date | 2013-03-18 |
| 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 | GS1302.21.01.1A |
| 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 | CANTON MA 02021 US 02021 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2014-07-11 |