MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2016-12-29 for SERI SURGICAL SCAFFOLD (US) SCF10X25AGEN manufactured by Allergan (medford).
[63609839]
(b)(4). Allergan is unable to confirm with the healthcare professional, therefore additional event, product, or patient details are not attainable. The reported events are physiological complications, and analysis of the device generally does not assist allergan in determining a probable cause for these events. The device has not been returned. Therefore, no analysis or testing has been done.
Patient Sequence No: 1, Text Type: N, H10
[63609840]
Patient representative reported "pain", "swelling", seroma, "a significant amount of residual seri scaffold material present in the chest wall in the anterior wall flaps", "sleep disturbances", "chest heaviness", "thinning of the tissues", "tightness", "mental and nervous pain and suffering, fright, grief, anxiety, and apprehension? , and aesthetic symptoms which were? Disturbing?. Patient complained that they experienced? Chest pain, discomfort, tightness, and sleep disturbance? ? Hurt and injured in [their] health, strength, and activity, sustaining injury to [their] body, and shock and injury to [their] nervous system and person, all of which have caused and continue to cause permanent injury in [their] health and physical ability mental and nervous pain and suffering, fright, grief, anxiety, and apprehension.? Per records, early 2015 patient underwent? Double mastectomy with nipple preservation followed by bilateral breast reconstruction using tissue expanders and seri surgical scaffold. In (b)(6) 2015 patient underwent replacement of tissue expanders with silicone gel breast implants during which it was noted that there were sections of seri which were not integrated and were removed. In (b)(6) 2015, patient underwent revision reconstruction during which it was noted that? The previously placed seri scaffold was only visible on the chest wall. There was no seri scaffold noted on the mammoplasty skin flap which was in many parts non adherent.? In (b)(6) 2016, during another revision reconstruction, the surgeon? Removed the remaining non-adherent seri scaffold? And placed non-allergan surgical scaffold.
Patient Sequence No: 1, Text Type: D, B5
[74270717]
Device history record (dhr) results: from the review of the device history records for lot p14082201a, there is no evidence in the manufacturing history of lot p14082201a to suggest that a manufacturing error caused the complaint reported.
Patient Sequence No: 1, Text Type: N, H10
[74270718]
Patient representative reported "pain", "swelling", seroma, "a significant amount of residual seri scaffold material present in the chest wall in the anterior wall flaps", "sleep disturbances", "chest heaviness", "thinning of the tissues", "tightness", "mental and nervous pain and suffering, fright, grief, anxiety, and apprehension? , and aesthetic symptoms which were? Disturbing?. Patient complained that they experienced? Chest pain, discomfort, tightness, and sleep disturbance? ? Hurt and injured in [their] health, strength, and activity, sustaining injury to [their] body, and shock and injury to [their] nervous system and person, all of which have caused and continue to cause permanent injury in [their] health and physical ability mental and nervous pain and suffering, fright, grief, anxiety, and apprehension.? Per records, early 2015 patient underwent? Double mastectomy with nipple preservation followed by bilateral breast reconstruction using tissue expanders and seri? Surgical scaffold. In (b)(6) 2015 patient underwent replacement of tissue expanders with silicone gel breast implants during which it was noted that there were sections of seri? Which were not integrated and were removed. In (b)(6) 2015, patient underwent revision reconstruction during which it was noted that? The previously placed seri? Scaffold was only visible on the chest wall. There was no seri? Scaffold noted on the mammoplasty skin flap which was in many parts non adherent.? In (b)(6) 2016, during another revision reconstruction, the surgeon? Removed the remaining non-adherent seri scaffold? And placed non-allergan surgical scaffold.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020862-2016-00051 |
| MDR Report Key | 6214173 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2016-12-29 |
| Date of Report | 2017-04-21 |
| Date of Event | 2015-03-30 |
| Date Mfgr Received | 2017-04-03 |
| Device Manufacturer Date | 2014-10-31 |
| Date Added to Maude | 2016-12-29 |
| 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 | MS. SUZANNE WOJCIK |
| Manufacturer Street | 301 W HOWARD LANE SUITE 100 |
| Manufacturer City | AUSTIN TX 78753 |
| Manufacturer Country | US |
| Manufacturer Postal | 78753 |
| Manufacturer Phone | 7372473605 |
| Manufacturer G1 | ALLERGAN (MEDFORD) |
| Manufacturer Street | 200 BOSTON AVENUE |
| Manufacturer City | MEDFORD MA 02155 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02155 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SERI SURGICAL SCAFFOLD (US) |
| Generic Name | MESH, SURGICAL, ABSORBABLE, PLASTIC AND RECONSTRUCTIVE SURGERY |
| Product Code | OXF |
| Date Received | 2016-12-29 |
| Catalog Number | SCF10X25AGEN |
| Lot Number | P14082201A |
| Device Expiration Date | 2017-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALLERGAN (MEDFORD) |
| Manufacturer Address | 200 BOSTON AVENUE MEDFORD MA 02155 US 02155 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-12-29 |